BIBR 277 Capsule in Patients With Essential Hypertension

Study Overview
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Brief Summary
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The efficacy and safety of Telmisartan capsule in patients with essential hypertension were evaluated in comparison with Enalapril Maleate in the double blind trial.

Official Title
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A Double-blind, Parallel-group Comparison Study of BIBR 277 Capsule in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: BIBR277 low dose
* Drug: BIBR277 medium dose
* Drug: BIBR277 high dose
* Drug: Enalapril low dose
* Drug: Enalapril medium dose
* Drug: Enalapril high dose
* Drug: Placebo matching BIBR277
* Drug: Placebo matching enalapril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIBR277 and placebo matching enalapril<br> | Drug: BIBR277 low dose<br> <br> Drug: BIBR277 medium dose<br> <br> Drug: BIBR277 high dose<br> <br> Drug: Placebo matching enalapril<br> <br> |
| Active Comparator: Enalapril and placebo matching BIBR277<br> | Drug: Enalapril low dose<br> <br> Drug: Enalapril medium dose<br> <br> Drug: Enalapril high dose<br> <br> Drug: Placebo matching BIBR277<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antihypertensive effect |  | every 2 weeks up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of normalized blood pressure |  | every 2 weeks up to week 12 | 
| Occurrence of the adverse event cough |  | up to 12 weeks | 
| Decrease in blood pressure (mean systolic and diastolic blood pressure) |  | every 2 weeks up to week 12 |