Pharmacokinetics of BIBR 277 in Hypertensive Patients

Study Overview
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Brief Summary
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The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis

Official Title
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BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Low dose of BIBR 277
* Drug: Medium dose of BIBR 277
* Drug: High dose of BIBR 277


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: >=20 years Sex: Either male or female Patient status: Either inpatient or outpatient, provided that the patient was available for hospitalisation from the day before the trial medication administration until the morning of the day after administration BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before administration should be >= 150 mmHg and >= 90 mmHg, respectively. Patients undergoing treatment with other antihypertensives were not excluded provided the above criteria were satisfied. Exclusion Criteria: Malignant hypertension Renovascular hypertension Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or history of myocardial infarction (within 6 months of onset) Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia Symptoms of cerebrovascular disorder Serious hepatic dysfunction Renal function disorder (serum creatinine >= 4.0 mg/dL) Known hypersensitivity to angiotensin II receptor antagonists Hyperkalaemia (potassium >= 5.5 milliequivalents per liter (mEq/L)) Treatment with the other investigational drug within 6 months of initiation of the present study Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study Previous treatment with the trial medication of the present study Otherwise judged ineligible by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of BIBR 277<br> | Drug: Low dose of BIBR 277<br> <br> |
| Experimental: Medium dose of BIBR 277<br> | Drug: Medium dose of BIBR 277<br> <br> |
| Experimental: High dose of BIBR 277<br> | Drug: High dose of BIBR 277<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr) |  | Pre-dose up to 24 hours after start of treatment | 
| Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr) |  | Pre-dose up to 24 hours after start of treatment | 
| Maximum measured concentration of BIBR 277 in plasma (Cmax) |  | Pre-dose up to 24 hours after start of treatment | 
| Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax) |  | Pre-dose up to 24 hours after start of treatment | 
| Terminal elimination half-time of BIBR 277 in plasma (t1/2) |  | Pre-dose up to 24 hours after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in blood pressure (systolic, diastolic, and mean) |  | Pre-dose up to 14 days after start of treatment | 
| Changes from baseline in pulse rate |  | Pre-dose up to 14 days after start of treatment | 
| Number of patients with adverse events |  | Up to 29 days | 
| Changes from baseline in laboratory test values |  | Pre-dose up to 14 days after start of treatment |