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SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239538
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 8, 2013
Information provided by:
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus, Type 2 Drug: telmisartan combined with hydrochlorothiazide (80/12.5 mg) Drug: valsartan combined with hydrochlorothiazide (160/12.5mg) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : January 2003
Actual Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure. [ Time Frame: 10 weeks ]
  2. Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure. [ Time Frame: 10 weeks ]
  3. 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. [ Time Frame: 10 weeks ]
  4. Changes from baseline in SBP and DBP load during the 24-hour dosing interval. [ Time Frame: 10 weeks ]
  5. Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined [ Time Frame: 10 weeks ]
  6. 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. [ Time Frame: 4 weeks and 10 weeks ]
  7. Responder rates based on the mean seated trough cuff measurements [ Time Frame: 4 weeks and 10 weeks ]
  8. Metabolic and inflammatory marker changes from baseline [ Time Frame: up to 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239538

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator B.I. Canada Ltd.

Layout table for additonal information Identifier: NCT00239538    
Other Study ID Numbers: 502.399
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators