Pharmacokinetics of BIBR 277 in Hypertensive Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Medium dose of BIBR 277; Drug: Low dose of BIBR 277; Drug: High dose of BIBR 277

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187497

502.268

Details and patient eligibility

About

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

Enrollment: 93 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Low dose of BIBR 277

Experimental group

Treatment:

Drug: Low dose of BIBR 277

Medium dose of BIBR 277

Experimental group

Treatment:

Drug: Medium dose of BIBR 277

High dose of BIBR 277

Experimental group

Treatment:

Drug: High dose of BIBR 277