SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
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.
Diabetes Mellitus, Type 2
Drug: telmisartan combined with hydrochlorothiazide (80/12.5 mg)
Drug: valsartan combined with hydrochlorothiazide (160/12.5mg)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.|
- Changes following treatment in blood pressure during the last 6 hours of the 24-hour dosing interval as measured by automated blood pressure monitor. See Detailed Description for additional information.
- Various secondary outcomes related to 1) automated blood pressure monitoring; 2) in-clinic seated trough measurements and blood pressure-related response rates. See Detailed Description for additional information.
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2004|
Show 102 Study Locations
|Study Chair:||Boehringer Ingelheim Study Coordinator||B.I. Canada Ltd.|