Hypertension
Conditions
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
Interventions
DRUGLow dose of BIBR 277
DRUGMedium dose of BIBR 277
DRUGHigh dose of BIBR 277
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal elimination half-time of BIBR 277 in plasma (t1/2) | Pre-dose up to 24 hours after start of treatment |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes from baseline in blood pressure (systolic, diastolic, and mean) | Pre-dose up to 14 days after start of treatment |
Outcome results
None listed