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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

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.

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)

Eligibility

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

Criteria:

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

Locations and Contacts

Additional Information

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

Page last updated: August 23, 2015

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