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Completed

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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Key information

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

Low dose of BIBR 277

Drug

Medium dose of BIBR 277

Drug

High dose of BIBR 277

Drug

Primary outcomes

  1. 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

  2. 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

  3. Maximum measured concentration of BIBR 277 in plasma (Cmax)

    Time frame: Pre-dose up to 24 hours after start of treatment

  4. 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

  5. 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

  1. Changes from baseline in blood pressure (systolic, diastolic, and mean)

    Time frame: Pre-dose up to 14 days after start of treatment

  2. Changes from baseline in pulse rate

    Time frame: Pre-dose up to 14 days after start of treatment

  3. Number of patients with adverse events

    Time frame: Up to 29 days

  4. 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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