CompletedNCT02187497Updated Jul 11, 2014

Pharmacokinetics of BIBR 277 in Hypertensive Patients

A Phase 2 interventional study of Low dose of BIBR 277 and Medium dose of BIBR 277 in Hypertension, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 93
Allocation: Non-randomized
Ages: 20 Years and older
Sex: All

Study 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

Conditions studied

Hypertension

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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 93 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 93 participants (actual)

Study arms

Experimental
Low dose of BIBR 277
Drug: Low dose of BIBR 277
Experimental
Medium dose of BIBR 277
Drug: Medium dose of BIBR 277
Experimental
High dose of BIBR 277
Drug: High dose of BIBR 277

Interventions

DrugLow dose of BIBR 277
DrugMedium dose of BIBR 277
DrugHigh dose of BIBR 277

What researchers measure

Primary 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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02187497
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Jul 11, 2014
Start date: Jun 1998
Primary completion: Sep 1998
Last update: Jul 11, 2014

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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