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Pharmacokinetics of BIBR 277 in Hypertensive Patients

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Low dose of BIBR 277 (Drug); Medium dose of BIBR 277 (Drug); High dose of BIBR 277 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim


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

Clinical Details

Official title: BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)

Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)

Maximum measured concentration of BIBR 277 in plasma (Cmax)

Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)

Terminal elimination half-time of BIBR 277 in plasma (t1/2)

Secondary outcome:

Changes from baseline in blood pressure (systolic, diastolic, and mean)

Changes from baseline in pulse rate

Number of patients with adverse events

Changes from baseline in laboratory test values


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: June 1998
Last updated: July 9, 2014

Page last updated: August 23, 2015

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