Status:
COMPLETED
SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
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 co...
Detailed Description
Methodology: Prospective, randomised, open-label, blinded end-point, forced-titration, parallel group comparison using Ambulatory Blood Pressure Monitoring (ABPM). Planned/Actual Number of Subjects:...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00239538
Start Date
January 1 2003
End Date
December 1 2004
Last Update
November 8 2013
Active Locations (102)
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1
Cooper Green Hospital
Birmingham, Alabama, United States, 35223
2
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States, 35294-2041
3
Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States, 35801
4
Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States, 36608