SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
This study has been completed.
Information provided by:
Boehringer Ingelheim Pharmaceuticals
First received: October 14, 2005
Last updated: November 7, 2013
Last verified: November 2013
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
Diabetes Mellitus, Type 2
Drug: telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Drug: valsartan combined with hydrochlorothiazide (160/12.5mg)
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Changes from baseline in SBP and DBP load during the 24-hour dosing interval. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Responder rates based on the mean seated trough cuff measurements [ Time Frame: 4 weeks and 10 weeks ] [ Designated as safety issue: No ]
- Metabolic and inflammatory marker changes from baseline [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||December 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Ability to provide written informed consent.
- 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.
- 24-hour mean DBP of >= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit 3.
- 30 years of age or greater.
- Ability to stop current antihypertensive therapy and other disallowed medications without risk to the patient.
- Diagnosis of type-2 diabetes mellitus with HbA1C less than or equal to 10%.
- Overweight or obese as defined by a BMI >= 27 kg/m2 in non-Asians and >= 24 kg/m2 in Asians.
- Negative UPT for females.
- 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.
- Night shift workers
- Mean sitting SBP >= 180 mmHg or mean sitting DBP >= 110 mmHg during any visit of the placebo run-in period.
- Known or suspected secondary hypertension. Hepatic and/or renal dysfunction
- Fasting serum glucose > 17 mmol/l (or 300 mg/dl) at visit 2
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients on dialysis or post-renal transplant patients.
- Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Biliary obstructive disorders (e.g., cholestasis).
- Congestive heart failure
- Stroke within the past six months.
- Documented severe obstructive coronary artery disease.
- Myocardial infarction, cardiac surgery or unstable angina within the past three months.
- PCI (percutaneous coronary intervention) within the past three months or planned during trial period.
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
- Patients with type-1 diabetes mellitus.
- Patients who have previously experienced symptoms of angioedema during ACE or ARB treatment.
- History of drug or alcohol dependency in past six months.
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
- Any investigational drug therapy within the past month.
- Known hypersensitivity to any component of the study drug.
- Concurrent use of corticosteroids, colestipol or cholestyramine resins.
- Any clinical condition which would not allow safe completion of the protocol.
- Inability to comply with the protocol.
- Any surgery that is, at the time of screening, planned to take place during the study period.
- History of non-compliance with prescribed medications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239538
Boehringer Ingelheim Pharmaceuticals
||Boehringer Ingelheim Study Coordinator
||B.I. Canada Ltd.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2005
||November 7, 2013
||Canada: Therapeutic Products Directorate
U.S.A.: Food & Drug Administration
Mexico: Federal Commission for the Protection against Sanitary Risk
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Australia/New Zealand: Therapeutic Goods Administration/New Zealand Medicines and Medical Devices Safety Authority
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors