Clinical trial NCT02187497: Pharmacokinetics of BIBR 277 in Hypertensive Patients
Official title: BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)
timeFrame: Pre-dose up to 24 hours after start of treatment
measure: Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)
timeFrame: Pre-dose up to 24 hours after start of treatment
measure: Maximum measured concentration of BIBR 277 in plasma (Cmax)
timeFrame: Pre-dose up to 24 hours after start of treatment
measure: Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)
timeFrame: Pre-dose up to 24 hours after start of treatment
measure: Terminal elimination half-time of BIBR 277 in plasma (t1/2)
timeFrame: Pre-dose up to 24 hours after start of treatment
Secondary outcomes:
measure: Changes from baseline in blood pressure (systolic, diastolic, and mean)
timeFrame: Pre-dose up to 14 days after start of treatment
measure: Changes from baseline in pulse rate
timeFrame: Pre-dose up to 14 days after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 29 days
measure: Changes from baseline in laboratory test values
timeFrame: Pre-dose up to 14 days after start of treatment
Other outcomes:
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