BIBR 277 Capsule in Patients With Essential Hypertension

NCT02177448 | Completed Phase 3

• 1 other identifier: 502.267
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Antihypertensive effect

  every 2 weeks up to week 12

Secondary Outcomes (3)

• 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

Study Arms (2)

BIBR277 and placebo matching enalapril

EXPERIMENTAL

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

Enalapril and placebo matching BIBR277

ACTIVE COMPARATOR

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

Interventions

BIBR277 low dose DRUG

BIBR277 and placebo matching enalapril

BIBR277 medium dose DRUG

BIBR277 and placebo matching enalapril

BIBR277 high dose DRUG

BIBR277 and placebo matching enalapril

Enalapril low dose DRUG

Enalapril and placebo matching BIBR277

Enalapril medium dose DRUG

Enalapril and placebo matching BIBR277

Enalapril high dose DRUG

Enalapril and placebo matching BIBR277

Placebo matching BIBR277 DRUG

Enalapril and placebo matching BIBR277

Placebo matching enalapril DRUG

BIBR277 and placebo matching enalapril

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Enalapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: September 1, 1998
• Primary Completion: September 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07