Pharmacokinetics of BIBR 277 in Hypertensive Patients

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Medium dose of BIBR 277; Drug: Low dose of BIBR 277; Drug: High dose of BIBR 277

• Registration Number: NCT02187497
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 1998-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium dose of BIBR 277	Medium dose of BIBR 277	-
Low dose of BIBR 277	Low dose of BIBR 277	-
High dose of BIBR 277	High dose of BIBR 277	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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