SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
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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 4 |
| Study Type: | Interventional |
| 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.
| 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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Show 102 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Canada Ltd. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00239538 History of Changes |
| Other Study ID Numbers: | 502.399 |
| Study First Received: | October 14, 2005 |
| Last Updated: | May 18, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Valsartan Telmisartan Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013