Back to resultsBIBR 277 Capsule in Patients With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BIBR277 low dose
BIBR277 medium dose
BIBR277 high dose
Enalapril low dose
Enalapril medium dose
Enalapril high dose
Placebo matching BIBR277
Placebo matching enalapril
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIBR277 and placebo matching enalapril
Enalapril and placebo matching BIBR277
Arm Description
Outcomes
Primary Outcome Measures
Antihypertensive effect
Secondary Outcome Measures
Rate of normalized blood pressure
Occurrence of the adverse event cough
Decrease in blood pressure (mean systolic and diastolic blood pressure)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02177448
Brief Title
BIBR 277 Capsule in Patients With Essential Hypertension
Official Title
A Double-blind, Parallel-group Comparison Study of BIBR 277 Capsule in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
September 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIBR277 and placebo matching enalapril
Arm Type
Experimental
Arm Title
Enalapril and placebo matching BIBR277
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BIBR277 low dose
Intervention Type
Drug
Intervention Name(s)
BIBR277 medium dose
Intervention Type
Drug
Intervention Name(s)
BIBR277 high dose
Intervention Type
Drug
Intervention Name(s)
Enalapril low dose
Intervention Type
Drug
Intervention Name(s)
Enalapril medium dose
Intervention Type
Drug
Intervention Name(s)
Enalapril high dose
Intervention Type
Drug
Intervention Name(s)
Placebo matching BIBR277
Intervention Type
Drug
Intervention Name(s)
Placebo matching enalapril
Primary Outcome Measure Information:
Title
Antihypertensive effect
Time Frame
every 2 weeks up to week 12
Secondary Outcome Measure Information:
Title
Rate of normalized blood pressure
Time Frame
every 2 weeks up to week 12
Title
Occurrence of the adverse event cough
Time Frame
up to 12 weeks
Title
Decrease in blood pressure (mean systolic and diastolic blood pressure)
Time Frame
every 2 weeks up to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.267_U04-3306.pdf
Description
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BIBR 277 Capsule in Patients With Essential Hypertension
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