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BIBR 277 Capsule in Patients With Essential Hypertension

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim


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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Antihypertensive effect

Secondary outcome:

Rate of normalized blood pressure

Occurrence of the adverse event cough

Decrease in blood pressure (mean systolic and diastolic blood pressure)


Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: September 1998
Last updated: July 7, 2014

Page last updated: August 23, 2015

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