BIBR 277 Capsule in Patients With Essential Hypertension

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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: BIBR277 low dose; Drug: BIBR277 medium dose; Drug: BIBR277 high dose; Drug: Placebo matching enalapril; Drug: Enalapril low dose; Drug: Enalapril medium dose; Drug: Enalapril high dose; Drug: Placebo matching BIBR277

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBR277 and placebo matching enalapril	Drug: BIBR277 low dose; Drug: BIBR277 medium dose; Drug: BIBR277 high dose; Drug: Placebo matching enalapril
Active Comparator: Enalapril and placebo matching BIBR277	Drug: Enalapril low dose; Drug: Enalapril medium dose; Drug: Enalapril high dose; Drug: Placebo matching BIBR277

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Primary Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enalaprilat; Enalapril; Telmisartan
• Other Study ID Numbers: 502.267