SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

Completed · Phase 4

Conditions studied: Hypertension, Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT00239538

Run by

Boehringer Ingelheim

People needed

840

Starts

2003-01-01

Expected to finish

2004-12-01

Last updated by the study team

2013-11-08

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• Boehringer Ingelheim Investigational Site — Glendale, Arizona, United States
• Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• Memorial Research Medical Clinic — Long Beach, California, United States
• 1200 — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 8615 — Nuena Park, California, United States
• Boehringer Ingelheim Investigational Site — Orange, California, United States
• Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 595 — San Francisco, California, United States
• 1805 — Stockton, California, United States
• Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 2311 — Washington D.C., District of Columbia, United States
• Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 6448 — Hollywood, Florida, United States
• Boehringer Ingelheim Investigational Site — Melbourne, Florida, United States
• Attention: Larry I. Gilderman, D.O. — Pembroke Pines, Florida, United States
• Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• Boehringer Ingelheim Investigational Site — Pinellas Park, Florida, United States
• Cooper Green Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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