BIBR 277 Capsule in Patients With Essential Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: BIBR277 medium dose; Drug: Enalapril medium dose; Drug: Enalapril low dose; Drug: Enalapril high dose; Drug: BIBR277 high dose; Drug: Placebo matching BIBR277; Drug: BIBR277 low dose; Drug: Placebo matching enalapril

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177448

502.267

Details and patient eligibility

About

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

Enrollment: 225 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 2 patient groups

BIBR277 and placebo matching enalapril

Experimental group

Treatment:

Drug: BIBR277 high dose

Drug: BIBR277 low dose

Drug: BIBR277 medium dose

Drug: Placebo matching enalapril

Enalapril and placebo matching BIBR277

Active Comparator group

Treatment:

Drug: Enalapril low dose

Drug: Enalapril high dose

Drug: Enalapril medium dose

Drug: Placebo matching BIBR277