Clinical trial NCT02177448: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 225
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Antihypertensive effect
timeFrame: every 2 weeks up to week 12
Secondary outcomes:
measure: Rate of normalized blood pressure
timeFrame: every 2 weeks up to week 12
measure: Occurrence of the adverse event cough
timeFrame: up to 12 weeks
measure: Decrease in blood pressure (mean systolic and diastolic blood pressure)
timeFrame: every 2 weeks up to week 12
Other outcomes:
Locations:
Study officials:
References: