BIBR 277 Capsule in Patients With Essential Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: BIBR277 low dose; Drug: Enalapril low dose; Drug: BIBR277 medium dose; Drug: Enalapril medium dose; Drug: Enalapril high dose; Drug: BIBR277 high dose; Drug: Placebo matching enalapril; Drug: Placebo matching BIBR277

• Registration Number: NCT02177448
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-09
• Primary Completion: 1999-09
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enalapril and placebo matching BIBR277	Enalapril high dose	-
BIBR277 and placebo matching enalapril	BIBR277 low dose	-
BIBR277 and placebo matching enalapril	BIBR277 high dose	-
BIBR277 and placebo matching enalapril	BIBR277 medium dose	-
Enalapril and placebo matching BIBR277	Enalapril medium dose	-
BIBR277 and placebo matching enalapril	Placebo matching enalapril	-
Enalapril and placebo matching BIBR277	Placebo matching BIBR277	-
Enalapril and placebo matching BIBR277	Enalapril low dose	-

Primary Outcome Measures

Name	Time	Method
Antihypertensive effect	every 2 weeks up to week 12

Secondary Outcome Measures

Name	Time	Method
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