Pharmacokinetics of BIBR 277 in Hypertensive Patients

BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Low dose of BIBR 277; Drug: Medium dose of BIBR 277; Drug: High dose of BIBR 277

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose of BIBR 277	Drug: Low dose of BIBR 277
Experimental: Medium dose of BIBR 277	Drug: Medium dose of BIBR 277
Experimental: High dose of BIBR 277	Drug: High dose of BIBR 277

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): September 1, 1998

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.268