|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00239538 |
Purpose
Hypertension affects approximately one billion people worldwide. There is a strong relationship between high blood pressure (BP) and cardiovascular disease (CVD) risk and lowering BP can reduce this risk. This is especially important for hypertensive patients with other risk factors for CVD, such as diabetes and obesity, as these factors act additively to further increase CVD risk. In these "at-risk" patients, it has been recommended that BP should be reduced to less than 130/80 mmHg. To achieve this target, multiple antihypertensive medications are often required. The American Diabetes Association recommends that such a therapy should include BP medications from the ACE or ARB classes, depending on which is best tolerated. If BP targets remain unmet, a combination therapy that includes medication from the thiazide diuretic class is further recommended.
Telmisartan and valsartan are potent BP medications from the ARB class. Of note, telmisartan belongs to the second generation of ARBs with sustained 24-hr BP protection, including the early morning hours during which patients are at increased risk for cardiovascular complications. Telmisartan and valsartan are also available in combination with the diuretic hydrochlorothiazide (MICARDIS® PLUS/ MICARDIS® HCT and DIOVAN HCT®). Such formulations have an additive action and are able to produce greater BP reductions than either product alone and are particularly useful in at-risk patients where additional efficacy is needed to achieve BP control.
Given the above, the primary objective of the SMOOTH study was to demonstrate that, when combined with hydrochlorothiazide (12.5 mg), telmisartan (80 mg) is at least as effective and possibly superior to valsartan (160 mg) in lowering systolic and diastolic BP during the last 6 hours of the 24-hour dosing interval (i.e., the critical morning period) following a 10-week treatment period in hypertensive, overweight/obese Type-2 diabetics.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetes Mellitus, Type 2 |
Drug: telmisartan combined with hydrochlorothiazide (80/12.5 mg) Drug: valsartan combined with hydrochlorothiazide (160/12.5mg) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 846 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2004 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 102 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Canada Ltd. |
More Information
| Study ID Numbers: | 502.399 |
| Study First Received: | October 14, 2005 |
| Last Updated: | September 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00239538 History of Changes |
| Health Authority: | 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 |
|
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Valsartan Metabolic Diseases Vascular Diseases Diabetes Mellitus |
Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Natriuretic Agents Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Hypertension |