NCT02177448CompletedPhase 3
A Double-blind, Parallel-group Comparison Study of BIBR 277 Capsule in Patients With Essential Hypertension
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 225
- Primary Endpoint
- Antihypertensive effect
Study Overview
Brief Summary
The efficacy and safety of Telmisartan capsule in patients with essential hypertension were evaluated in comparison with Enalapril Maleate in the double blind trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is ≥ 25 years of age
- •Patient is either male or female
- •Outpatient. Change to inpatient is not allowed during the study period
- •Blood pressure is measured 3 times or more during the 4-week observation period; the last 2 measurements in the sitting position (intervals between measurements must be less than 4 weeks) are stabilized for both of systolic pressure (within +/- 30 mmHg) and diastolic pressure within +/- 15 mmHg) with the mean exceeding 160 mmHg for systolic and 95 mmHG for diastolic pressure
Exclusion Criteria
- •Patient has severe hypertension (the last 2 measurements in the observation period exceed 120 mmHg in terms of diastolic blood pressure)
- •Patient has secondary or malignant hypertension
- •Patient has a history of severe cardiac failure, unstable angina, or myocardial infarction within previous six months
- •Patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
- •Patient has any symptoms of cerebrovascular disorder
- •Patient has serious hepatic dysfunction (either GOT (glutamic-oxaloacetic transaminase) or GPT (glutamic-pyruvic transaminase) exceeds 100 U)
- •Patient has renal dysfunction (serum creatinin ≥ 2.1 mg/dl)
- •Patient has uncontrolled diabetic (either of the following tests exceeds the specified standards: fasting blood glucose exceeding 151 mg/dl or HbA1c exceeding 8%)
- •Patient has a history of drug sensitivity to ACE (angiotensin converting enzyme) inhibitors and angiotensin II receptor antagonists
- •Patient has a history of angioedema due to ACE inhibitors
- •Patient has hyperkalemia (K exceeding 5.5 mEq/l)
- •Patient has received enalapril just before the start of observation period
- •Patient has received treatment with any other investigational drug(s) within three months of the start of observation period
- •Patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
- •Patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
Arms & Interventions
Enalapril and placebo matching BIBR277
Active Comparator
Intervention: Placebo matching BIBR277 (Drug)
BIBR277 and placebo matching enalapril
Experimental
Intervention: BIBR277 low dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
Intervention: BIBR277 medium dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
Intervention: BIBR277 high dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
Intervention: Placebo matching enalapril (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
Intervention: Enalapril low dose (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
Intervention: Enalapril medium dose (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
Intervention: Enalapril high dose (Drug)
Outcomes
Primary Outcomes
Antihypertensive effect
Time Frame: every 2 weeks up to week 12
Secondary Outcomes
- Decrease in blood pressure (mean systolic and diastolic blood pressure)(every 2 weeks up to week 12)
- Rate of normalized blood pressure(every 2 weeks up to week 12)
- Occurrence of the adverse event cough(up to 12 weeks)
Investigators
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