NCT Number: NCT02187497
Pharmacokinetics of BIBR 277 in 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
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Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Medium dose of BIBR 277
DrugHigh dose of BIBR 277
DrugPrimary outcomes
-
Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)
Time frame: 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)
Time frame: Pre-dose up to 24 hours after start of treatment
-
Maximum measured concentration of BIBR 277 in plasma (Cmax)
Time frame: Pre-dose up to 24 hours after start of treatment
-
Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)
Time frame: Pre-dose up to 24 hours after start of treatment
-
Terminal elimination half-time of BIBR 277 in plasma (t1/2)
Time frame: Pre-dose up to 24 hours after start of treatment
Secondary outcomes
-
Changes from baseline in blood pressure (systolic, diastolic, and mean)
Time frame: Pre-dose up to 14 days after start of treatment
-
Changes from baseline in pulse rate
Time frame: Pre-dose up to 14 days after start of treatment
-
Number of patients with adverse events
Time frame: Up to 29 days
-
Changes from baseline in laboratory test values
Time frame: Pre-dose up to 14 days after start of treatment
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients
Important dates
- Study start
- 1998
- Primary completion
- 1998
- First posted
- Jul 11, 2014
- Registry last updated
- Jul 11, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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