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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00379769




Registration number
NCT00379769
Ethics application status
Date submitted
21/09/2006
Date registered
22/09/2006

Titles & IDs
Public title
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Scientific title
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Secondary ID [1] 0 0
BRL-049653/231
Universal Trial Number (UTN)
Trial acronym
RECORD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone
Treatment: Drugs - Sulfonylurea
Treatment: Drugs - Metformin

Experimental: rosiglitazone in addition to background metformin - Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Experimental: rosiglitazone in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Active comparator: Sulfonylurea in addition to background metformin - Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Active comparator: Metformin in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.


Treatment: Drugs: Rosiglitazone
Rosiglitazone maximum 8 mg per day

Treatment: Drugs: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose

Treatment: Drugs: Metformin
Metformin maximum permitted daily dose .
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
Timepoint [1] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [2] 0 0
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
Timepoint [2] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [3] 0 0
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
Timepoint [3] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [4] 0 0
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
Timepoint [4] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [5] 0 0
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
Timepoint [5] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [6] 0 0
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
Timepoint [6] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [7] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Timepoint [7] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [8] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
Timepoint [8] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [9] 0 0
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Timepoint [9] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [10] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
Timepoint [10] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [1] 0 0
Number of Participants With Cardiovascular Events and All-cause Deaths
Timepoint [1] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [2] 0 0
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
Timepoint [2] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [3] 0 0
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
Timepoint [3] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [4] 0 0
Number of Participants With CV/Microvascular Events
Timepoint [4] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [5] 0 0
Number of Participants With Glycaemic Failure Events
Timepoint [5] 0 0
Baseline through to end of randomised dual therapy
Secondary outcome [6] 0 0
Number of Participants With Addition of Third Oral Agent/Switch to Insulin
Timepoint [6] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [7] 0 0
The Number of Participants Starting Insulin at Any Time During the Study
Timepoint [7] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [8] 0 0
Model Adjusted Change From Baseline in HbA1c at Month 60
Timepoint [8] 0 0
Baseline and Month 60 of randomised dual therapy treatment period
Secondary outcome [9] 0 0
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
Timepoint [9] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [10] 0 0
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
Timepoint [10] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [11] 0 0
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
Timepoint [11] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [12] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
Timepoint [12] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [13] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
Timepoint [13] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [14] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
Timepoint [14] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [15] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
Timepoint [15] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [16] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
Timepoint [16] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [17] 0 0
Model Adjusted Change From Baseline in Body Weight at Month 60
Timepoint [17] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [18] 0 0
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
Timepoint [18] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [19] 0 0
Model Adjusted Change From Baseline in Waist Circumference at Month 60
Timepoint [19] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [20] 0 0
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
Timepoint [20] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [21] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
Timepoint [21] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [22] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
Timepoint [22] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [23] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
Timepoint [23] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [24] 0 0
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
Timepoint [24] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [25] 0 0
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
Timepoint [25] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [26] 0 0
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined
Timepoint [26] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [27] 0 0
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up
Timepoint [27] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [28] 0 0
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
Timepoint [28] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [29] 0 0
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
Timepoint [29] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [30] 0 0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
Timepoint [30] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [31] 0 0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
Timepoint [31] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [32] 0 0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
Timepoint [32] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [33] 0 0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
Timepoint [33] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [34] 0 0
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
Timepoint [34] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [35] 0 0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
Timepoint [35] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [36] 0 0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
Timepoint [36] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [37] 0 0
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
Timepoint [37] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [38] 0 0
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
Timepoint [38] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [39] 0 0
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
Timepoint [39] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [40] 0 0
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
Timepoint [40] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [41] 0 0
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
Timepoint [41] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [42] 0 0
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
Timepoint [42] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [43] 0 0
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
Timepoint [43] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Eligibility
Key inclusion criteria
* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index >25.0 kg/m2.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Open (masking not 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
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
4447
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Miranda
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [4] 0 0
GSK Investigational Site - Carina Heights
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [7] 0 0
GSK Investigational Site - Keswick
Recruitment hospital [8] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [9] 0 0
GSK Investigational Site - Port Lincoln
Recruitment hospital [10] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [11] 0 0
GSK Investigational Site - Malvern
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4152 - Carina Heights
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
4075 - Sherwood
Recruitment postcode(s) [7] 0 0
5035 - Keswick
Recruitment postcode(s) [8] 0 0
5006 - North Adelaide
Recruitment postcode(s) [9] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Arlon
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Belgium
State/province [5] 0 0
Genk
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Liège
Country [9] 0 0
Belgium
State/province [9] 0 0
Moerkerke
Country [10] 0 0
Belgium
State/province [10] 0 0
Oostham
Country [11] 0 0
Belgium
State/province [11] 0 0
Roeselare
Country [12] 0 0
Belgium
State/province [12] 0 0
Sint Gillis-Waas
Country [13] 0 0
Belgium
State/province [13] 0 0
Vilvoorde
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Varna
Country [18] 0 0
Croatia
State/province [18] 0 0
Krapinske Toplice
Country [19] 0 0
Croatia
State/province [19] 0 0
Rijeka
Country [20] 0 0
Croatia
State/province [20] 0 0
Slavonski Brod
Country [21] 0 0
Croatia
State/province [21] 0 0
Varaždin
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Brno
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Ceske Budejovice
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Holice V Cechach
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Jindrichuv Hradec
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Ostrava Poruba
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Pisek
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Praha 2
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Praha 4
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Rakovnik
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Tabor
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Trutnov
Country [35] 0 0
Denmark
State/province [35] 0 0
Aalborg
Country [36] 0 0
Denmark
State/province [36] 0 0
Aarhus
Country [37] 0 0
Denmark
State/province [37] 0 0
Copenhagen
Country [38] 0 0
Denmark
State/province [38] 0 0
Glostrup
Country [39] 0 0
Denmark
State/province [39] 0 0
Hilleroed
Country [40] 0 0
Denmark
State/province [40] 0 0
Koge
Country [41] 0 0
Denmark
State/province [41] 0 0
Kolding
Country [42] 0 0
Denmark
State/province [42] 0 0
København NV
Country [43] 0 0
Denmark
State/province [43] 0 0
Naestved
Country [44] 0 0
Denmark
State/province [44] 0 0
Odense C
Country [45] 0 0
Denmark
State/province [45] 0 0
Silkeborg
Country [46] 0 0
Denmark
State/province [46] 0 0
Slagelse
Country [47] 0 0
Estonia
State/province [47] 0 0
Paide
Country [48] 0 0
Estonia
State/province [48] 0 0
Parnu
Country [49] 0 0
Estonia
State/province [49] 0 0
Rakvere
Country [50] 0 0
Estonia
State/province [50] 0 0
Saku
Country [51] 0 0
Estonia
State/province [51] 0 0
Tallinn
Country [52] 0 0
Estonia
State/province [52] 0 0
Tartu
Country [53] 0 0
Estonia
State/province [53] 0 0
Viljandi
Country [54] 0 0
Finland
State/province [54] 0 0
Espoo
Country [55] 0 0
Finland
State/province [55] 0 0
Hanko
Country [56] 0 0
Finland
State/province [56] 0 0
Helsinki
Country [57] 0 0
Finland
State/province [57] 0 0
Hyvinkaa
Country [58] 0 0
Finland
State/province [58] 0 0
Jyväskylä
Country [59] 0 0
Finland
State/province [59] 0 0
Kerava
Country [60] 0 0
Finland
State/province [60] 0 0
Kuopio
Country [61] 0 0
Finland
State/province [61] 0 0
Lahti
Country [62] 0 0
Finland
State/province [62] 0 0
Lappeenranta
Country [63] 0 0
Finland
State/province [63] 0 0
Oulun kaupunki
Country [64] 0 0
Finland
State/province [64] 0 0
Riihimäki
Country [65] 0 0
Finland
State/province [65] 0 0
Rovaniemi
Country [66] 0 0
Finland
State/province [66] 0 0
Seinajoki
Country [67] 0 0
Finland
State/province [67] 0 0
Tampere
Country [68] 0 0
Finland
State/province [68] 0 0
Turku
Country [69] 0 0
France
State/province [69] 0 0
Nord-Pas-de-Calais
Country [70] 0 0
France
State/province [70] 0 0
Amilly
Country [71] 0 0
France
State/province [71] 0 0
Arras
Country [72] 0 0
France
State/province [72] 0 0
Aspach le Bas 68700
Country [73] 0 0
France
State/province [73] 0 0
Aubagne
Country [74] 0 0
France
State/province [74] 0 0
Auchy les Hesdin
Country [75] 0 0
France
State/province [75] 0 0
Azille
Country [76] 0 0
France
State/province [76] 0 0
Beaumont Le Roger
Country [77] 0 0
France
State/province [77] 0 0
Beaumont sur Leze
Country [78] 0 0
France
State/province [78] 0 0
Belfort
Country [79] 0 0
France
State/province [79] 0 0
Belpech
Country [80] 0 0
France
State/province [80] 0 0
Blotzheim
Country [81] 0 0
France
State/province [81] 0 0
Bondy
Country [82] 0 0
France
State/province [82] 0 0
BP 1542 Dijon
Country [83] 0 0
France
State/province [83] 0 0
Broglie
Country [84] 0 0
France
State/province [84] 0 0
Calmont
Country [85] 0 0
France
State/province [85] 0 0
Carbonne
Country [86] 0 0
France
State/province [86] 0 0
Carcassonne 11000
Country [87] 0 0
France
State/province [87] 0 0
Carcassonne
Country [88] 0 0
France
State/province [88] 0 0
Cassis
Country [89] 0 0
France
State/province [89] 0 0
Castelnaudary
Country [90] 0 0
France
State/province [90] 0 0
Catelnaudary
Country [91] 0 0
France
State/province [91] 0 0
Cernay
Country [92] 0 0
France
State/province [92] 0 0
Champhol
Country [93] 0 0
France
State/province [93] 0 0
Chartres
Country [94] 0 0
France
State/province [94] 0 0
Colmar
Country [95] 0 0
France
State/province [95] 0 0
Corbeil Essonne
Country [96] 0 0
France
State/province [96] 0 0
Coursan
Country [97] 0 0
France
State/province [97] 0 0
Cuincy
Country [98] 0 0
France
State/province [98] 0 0
Danjoutin
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France
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Bucharest
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Romania
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Romania
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Craiova
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Iasi
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Romania
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Derbyshire
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Lanarkshire
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United Kingdom
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Somerset
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United Kingdom
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Warwickshire
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United Kingdom
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Wiltshire
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United Kingdom
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Airdrie
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Ashford
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East Kilbride
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United Kingdom
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Falmouth
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Garston, Watford
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United Kingdom
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Gateshead
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United Kingdom
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Glasgow
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Harrow
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Kirkintilloch
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Leigh on Sea
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Motherwell
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Newcastle upon Tyne
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Newport
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Nottingham
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Old Whittington, Chesterfield
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Paisley
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Penzance
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Rubery, Birmingham
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Sheffield
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Thornhill, Cardiff
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Thornhill
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Uddingston
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Weston Super Mare
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Wishaw
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Woking
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Worle, Weston-Super-Mare

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00379769