NCT00239538CompletedPhase 4
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 840
- Locations
- 132
- Primary Endpoint
- Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)
Study Overview
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 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
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:
Enrolled: 1500/2085; Randomised: 750/840; Complete: 680/752
Diagnosis and Main Criteria for Inclusion:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- 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
- •24-hour mean DBP of >= 85 mmHg, and/or SBP = 130 mmHg, measured by ABPM at Visit
- •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.
Outcomes
Primary Outcomes
Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)
Time Frame: 10 weeks
Secondary Outcomes
- Metabolic and inflammatory marker changes from baseline(up to 10 weeks)
- Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure.(10 weeks)
- Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure.(10 weeks)
- Changes from baseline in the ABPM mean (relative to clock time) for SBP, DBP, and pulse pressure during the morning, daytime and night time periods of the 24-hour dosing interval.(10 weeks)
- Changes from baseline in SBP and DBP load during the 24-hour dosing interval.(10 weeks)
- Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined(10 weeks)
- In-clinic trough cuff blood pressure measures at the end of both a 4-week (Visit 4) treatment period and a 10-week (Visit 6) treatment period.(4 weeks and 10 weeks)
- Responder rates based on the mean seated trough cuff measurements(4 weeks and 10 weeks)
Investigators
Study Sites (132)
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