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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00144339




Registration number
NCT00144339
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
20/05/2014

Titles & IDs
Public title
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 0 0
205.235
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tiotropium
Treatment: Drugs - placebo

Treatment: Drugs: tiotropium


Treatment: Drugs: placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years - Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Timepoint [1] 0 0
From day 30 to 4 years
Primary outcome [2] 0 0
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years - Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.
Timepoint [2] 0 0
From day 30 to 4 years
Secondary outcome [1] 0 0
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Timepoint [1] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Secondary outcome [2] 0 0
Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1
Timepoint [2] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [3] 0 0
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years - Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Timepoint [3] 0 0
From day 30 to 4 years
Secondary outcome [4] 0 0
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years - Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Timepoint [4] 0 0
From day 30 to 4 years
Secondary outcome [5] 0 0
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years - Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Timepoint [5] 0 0
From day 30 to 4 years
Secondary outcome [6] 0 0
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years - Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Timepoint [6] 0 0
From day 30 to 4 years
Secondary outcome [7] 0 0
Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score - SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).
Timepoint [7] 0 0
From month 6 to 4 years
Secondary outcome [8] 0 0
Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Timepoint [8] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.
Secondary outcome [9] 0 0
Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC
Timepoint [9] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [10] 0 0
Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Timepoint [10] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [11] 0 0
Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment - Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC
Timepoint [11] 0 0
Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days
Secondary outcome [12] 0 0
Time to First Exacerbation - Chronic obstructive pulmonary disease (COPD) exacerbation
Timepoint [12] 0 0
From Day 1 to 4 years
Secondary outcome [13] 0 0
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year
Timepoint [13] 0 0
Day 1 to 4 years
Secondary outcome [14] 0 0
Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Timepoint [14] 0 0
Day 1 to 4 years
Secondary outcome [15] 0 0
Number of Exacerbation Days Per Patient Year - Number of exacerbation days normalized by treatment exposure
Timepoint [15] 0 0
Day 1 to 4 years
Secondary outcome [16] 0 0
Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)
Timepoint [16] 0 0
Day 1 to 4 years
Secondary outcome [17] 0 0
Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization
Timepoint [17] 0 0
From Day 1 to 4 years
Secondary outcome [18] 0 0
Number of Exacerbation Leading to Hospitalization - Estimated number of exacerbations leading to hospitalizations per patient year
Timepoint [18] 0 0
From Day 1 to 4 years
Secondary outcome [19] 0 0
Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization - Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)
Timepoint [19] 0 0
From Day 1 to 4 years
Secondary outcome [20] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 - Estimated FEV1 before bronchodilator at Month 1
Timepoint [20] 0 0
Month 1
Secondary outcome [21] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 - Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1
Timepoint [21] 0 0
Month 1
Secondary outcome [22] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 - Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6
Timepoint [22] 0 0
Month 6
Secondary outcome [23] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6
Timepoint [23] 0 0
Month 6
Secondary outcome [24] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Timepoint [24] 0 0
Month 12
Secondary outcome [25] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12
Timepoint [25] 0 0
Month 12
Secondary outcome [26] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Timepoint [26] 0 0
Month 18
Secondary outcome [27] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18
Timepoint [27] 0 0
Month 18
Secondary outcome [28] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Timepoint [28] 0 0
Month 24
Secondary outcome [29] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24
Timepoint [29] 0 0
Month 24
Secondary outcome [30] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Timepoint [30] 0 0
Month 30
Secondary outcome [31] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30
Timepoint [31] 0 0
Month 30
Secondary outcome [32] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Timepoint [32] 0 0
Month 36
Secondary outcome [33] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36
Timepoint [33] 0 0
Month 36
Secondary outcome [34] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42
Timepoint [34] 0 0
Month 42
Secondary outcome [35] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 - Estimated FEV1 after bronchodilator at Month 42
Timepoint [35] 0 0
Month 42
Secondary outcome [36] 0 0
Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Timepoint [36] 0 0
Month 48
Secondary outcome [37] 0 0
Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48
Timepoint [37] 0 0
Month 48
Secondary outcome [38] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1
Timepoint [38] 0 0
Month 1
Secondary outcome [39] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1
Timepoint [39] 0 0
Month 1
Secondary outcome [40] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6
Timepoint [40] 0 0
Month 6
Secondary outcome [41] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6
Timepoint [41] 0 0
Month 6
Secondary outcome [42] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12
Timepoint [42] 0 0
Month 12
Secondary outcome [43] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12
Timepoint [43] 0 0
Month 12
Secondary outcome [44] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18
Timepoint [44] 0 0
Month 18
Secondary outcome [45] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18
Timepoint [45] 0 0
Month 18
Secondary outcome [46] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24
Timepoint [46] 0 0
Month 24
Secondary outcome [47] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24
Timepoint [47] 0 0
Month 24
Secondary outcome [48] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30
Timepoint [48] 0 0
Month 30
Secondary outcome [49] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
Timepoint [49] 0 0
Month 30
Secondary outcome [50] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36
Timepoint [50] 0 0
Month 36
Secondary outcome [51] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36
Timepoint [51] 0 0
Month 36
Secondary outcome [52] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42
Timepoint [52] 0 0
Month 42
Secondary outcome [53] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42
Timepoint [53] 0 0
Month 42
Secondary outcome [54] 0 0
Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48
Timepoint [54] 0 0
Month 48
Secondary outcome [55] 0 0
Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48
Timepoint [55] 0 0
Month 48
Secondary outcome [56] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1
Timepoint [56] 0 0
Month 1
Secondary outcome [57] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1
Timepoint [57] 0 0
Month 1
Secondary outcome [58] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6
Timepoint [58] 0 0
Month 6
Secondary outcome [59] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6
Timepoint [59] 0 0
Month 6
Secondary outcome [60] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12
Timepoint [60] 0 0
Month 12
Secondary outcome [61] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12
Timepoint [61] 0 0
Month 12
Secondary outcome [62] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18
Timepoint [62] 0 0
Month 18
Secondary outcome [63] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18
Timepoint [63] 0 0
Month 18
Secondary outcome [64] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24
Timepoint [64] 0 0
Month 24
Secondary outcome [65] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24
Timepoint [65] 0 0
Month 24
Secondary outcome [66] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30
Timepoint [66] 0 0
Month 30
Secondary outcome [67] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30
Timepoint [67] 0 0
Month 30
Secondary outcome [68] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36
Timepoint [68] 0 0
Month 36
Secondary outcome [69] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36
Timepoint [69] 0 0
Month 36
Secondary outcome [70] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42
Timepoint [70] 0 0
Month 42
Secondary outcome [71] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42
Timepoint [71] 0 0
Month 42
Secondary outcome [72] 0 0
Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48
Timepoint [72] 0 0
Month 48
Secondary outcome [73] 0 0
Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48
Timepoint [73] 0 0
Month 48
Secondary outcome [74] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [74] 0 0
Month 6
Secondary outcome [75] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [75] 0 0
Month 12
Secondary outcome [76] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [76] 0 0
Month 18
Secondary outcome [77] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [77] 0 0
Month 24
Secondary outcome [78] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [78] 0 0
Month 30
Secondary outcome [79] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [79] 0 0
Month 36
Secondary outcome [80] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [80] 0 0
Month 42
Secondary outcome [81] 0 0
Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 - SGRQ total score summarizes the impact of COPD on overall patient's health status.
Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
The scale is continuous.
Rate of decline shows the yearly change of SGRQ total score.
Timepoint [81] 0 0
Month 48
Secondary outcome [82] 0 0
Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) - On-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Timepoint [82] 0 0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Secondary outcome [83] 0 0
Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) - All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.
Timepoint [83] 0 0
Day 1 to day 1470
Secondary outcome [84] 0 0
Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) - The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days
Timepoint [84] 0 0
Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days
Secondary outcome [85] 0 0
Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) - The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used
Timepoint [85] 0 0
Day 1 to day 1470

Eligibility
Key inclusion criteria
- Written informed consent.

- Male or female patients 40 years of age or older.

- Smoking history of at least 10 pack years.

- Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted
normal and FEV1<70% of FVC and on stable respiratory medication.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant diseases other than COPD which in the opinion of the investigator may put
the patient at risk or influence the patients ability to participate.

- Myocardial infarction in past 6 months.

- Unstable or life threatening arrhythmia in past year.

- Hospitalization for NYHA heart failure class III or IV in past year.

- Active tuberculosis.

- Asthma.

- Pulmonary resection.

- Malignancy treated with radiation or chemotherapy in past 5 years.

- Respiratory infection in 4 weeks prior to screening.

- Known hypersensitivity to anticholinergic drugs or components.

- Known moderate to severe renal impairment.

- Known narrow angle glaucoma.

- Significant symptomatic BPH or bladder neck obstruction.

- Need for oxygen therapy >12 hr/day.

- Use of oral corticosteroids at unstable doses or >10 mg/day.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
205.235.0205 Boehringer Ingelheim Investigational Site - Bankstown
Recruitment hospital [2] 0 0
205.235.0202 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [3] 0 0
205.235.0209 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
205.235.0204 Boehringer Ingelheim Investigational Site - Cairns
Recruitment hospital [5] 0 0
205.235.0203 Boehringer Ingelheim Investigational Site - Redcliffe
Recruitment hospital [6] 0 0
205.235.0207 Boehringer Ingelheim Investigational Site - Port Lincoln
Recruitment hospital [7] 0 0
205.235.0206 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
205.235.0201 Boehringer Ingelheim Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Redcliffe
Recruitment postcode(s) [6] 0 0
- Port Lincoln
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Capital Federal
Country [37] 0 0
Argentina
State/province [37] 0 0
Parque Velez Sarlfield
Country [38] 0 0
Argentina
State/province [38] 0 0
Rosario
Country [39] 0 0
Argentina
State/province [39] 0 0
Vicente López
Country [40] 0 0
Austria
State/province [40] 0 0
Graz
Country [41] 0 0
Austria
State/province [41] 0 0
Innsbruck
Country [42] 0 0
Austria
State/province [42] 0 0
Leoben
Country [43] 0 0
Austria
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Czech Republic
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Czech Republic
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Czech Republic
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Czech Republic
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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