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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00239538




Registration number
NCT00239538
Ethics application status
Date submitted
14/10/2005
Date registered
17/10/2005
Date last updated
8/11/2013

Titles & IDs
Public title
SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
Scientific title
Prospective, Randomized, Open-label, Blinded Endpoint, Forced Titration Study to Compare Telmisartan Combined With HCTZ (80mg/12.5mg), to Valsartan Combined With HCTZ (160mg/12.5mg), for the Control of Mild-to-moderate Hypertension in Obese Patients With Type 2 Diabetes Mellitus Using ABPM.
Secondary ID [1] 0 0
502.399
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Treatment: Drugs - valsartan combined with hydrochlorothiazide (160/12.5mg)

Treatment: Drugs: telmisartan combined with hydrochlorothiazide (80/12.5 mg)


Treatment: Drugs: valsartan combined with hydrochlorothiazide (160/12.5mg)


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

Outcomes
Primary outcome [1] 0 0
Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)
Timepoint [1] 0 0
10 weeks
Secondary outcome [1] 0 0
Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure.
Timepoint [1] 0 0
10 weeks
Secondary outcome [2] 0 0
Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure.
Timepoint [2] 0 0
10 weeks
Secondary outcome [3] 0 0
Changes from baseline in the ABPM mean (relative to clock time) for SBP, DBP, and pulse pressure during the morning, daytime and night time periods of the 24-hour dosing interval.
Timepoint [3] 0 0
10 weeks
Secondary outcome [4] 0 0
Changes from baseline in SBP and DBP load during the 24-hour dosing interval.
Timepoint [4] 0 0
10 weeks
Secondary outcome [5] 0 0
Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined
Timepoint [5] 0 0
10 weeks
Secondary outcome [6] 0 0
In-clinic trough cuff blood pressure measures at the end of both a 4-week (Visit 4) treatment period and a 10-week (Visit 6) treatment period.
Timepoint [6] 0 0
4 weeks and 10 weeks
Secondary outcome [7] 0 0
Responder rates based on the mean seated trough cuff measurements
Timepoint [7] 0 0
4 weeks and 10 weeks
Secondary outcome [8] 0 0
Metabolic and inflammatory marker changes from baseline
Timepoint [8] 0 0
up to 10 weeks

Eligibility
Key inclusion criteria
1. Ability to provide written informed consent.

2. Hypertension defined as a mean seated DBP of 95-109 (inclusive) mmHg, and/or SBP of
140-179 (inclusive) mmHg, measured by BpTRU electronic or manual cuff at Visit 2.

3. 24-hour mean DBP of >= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.

4. 30 years of age or greater.

5. Ability to stop current antihypertensive therapy and other disallowed medications
without risk to the patient.

6. Diagnosis of type-2 diabetes mellitus with HbA1C less than or equal to 10%.

7. Overweight or obese as defined by a BMI >= 27 kg/m2 in non-Asians and >= 24 kg/m2 in
Asians.

8. Negative UPT for females.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-menopausal women, not surgically sterile or, not nursing/pregnant or are of
child-bearing potential and will not practice acceptable methods of birth control
during study.

2. Night shift workers

3. Mean sitting SBP >= 180 mmHg or mean sitting DBP >= 110 mmHg during any visit of the
placebo run-in period.

4. Known or suspected secondary hypertension. Hepatic and/or renal dysfunction

5. Fasting serum glucose > 17 mmol/l (or 300 mg/dl) at visit 2

6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients
on dialysis or post-renal transplant patients.

7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.

8. Uncorrected volume depletion.

9. Primary aldosteronism.

10. Hereditary fructose intolerance.

11. Biliary obstructive disorders (e.g., cholestasis).

12. Congestive heart failure

13. Stroke within the past six months.

14. Documented severe obstructive coronary artery disease.

15. Myocardial infarction, cardiac surgery or unstable angina within the past three
months.

16. PCI (percutaneous coronary intervention) within the past three months or planned
during trial period.

17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other
clinically relevant cardiac arrhythmias.

18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
stenosis of the aortic or mitral valve.

19. Patients with type-1 diabetes mellitus.

20. Patients who have previously experienced symptoms of angioedema during ACE or ARB
treatment.

21. History of drug or alcohol dependency in past six months.

22. Chronic administration of any medications known to affect blood pressure, except
medication allowed by the protocol.

23. Any investigational drug therapy within the past month.

24. Known hypersensitivity to any component of the study drug.

25. Concurrent use of corticosteroids, colestipol or cholestyramine resins.

26. Any clinical condition which would not allow safe completion of the protocol.

27. Inability to comply with the protocol.

28. Any surgery that is, at the time of screening, planned to take place during the study
period.

29. History of non-compliance with prescribed medications.

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 4
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)
QLD,VIC
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Kippa-Ring
Recruitment hospital [2] 0 0
Emeritus Research - Malvern
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
4021 - Kippa-Ring
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3181 - Prahran
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
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
BsAs
Country [26] 0 0
Argentina
State/province [26] 0 0
Coronel Suárez
Country [27] 0 0
Argentina
State/province [27] 0 0
Rosario, Sta. Fe
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
Newfoundland and Labrador
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Canada
State/province [34] 0 0
Saskatchewan
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Busan
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Daegu
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Mexico
State/province [38] 0 0
Col. Del Valle
Country [39] 0 0
Mexico
State/province [39] 0 0
Col. Magdalena de las Salinas
Country [40] 0 0
Mexico
State/province [40] 0 0
Col. Sección 16, México, D.F.
Country [41] 0 0
Mexico
State/province [41] 0 0
Guadalajara, Jalisco
Country [42] 0 0
Mexico
State/province [42] 0 0
Zapopan, Jalisco
Country [43] 0 0
New Zealand
State/province [43] 0 0
Auckland
Country [44] 0 0
New Zealand
State/province [44] 0 0
Christchurch
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to demonstrate that telmisartan 80 mg combined with
hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to
valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean
ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6
hours of the 24-hour dosing interval at the end of a 10-week treatment period in
mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus
Trial website
https://clinicaltrials.gov/show/NCT00239538
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
B.I. Canada Ltd.
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

Summary results
Other publications