NCT02187497

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_2 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1998

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

July 9, 2014

Last Update Submit

July 9, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

  • 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

  • Terminal elimination half-time of BIBR 277 in plasma (t1/2)

    Pre-dose up to 24 hours after start of treatment

Secondary Outcomes (4)

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

    Pre-dose up to 14 days after start of treatment

  • 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

Study Arms (3)

Low dose of BIBR 277

EXPERIMENTAL
Drug: Low dose of BIBR 277

Medium dose of BIBR 277

EXPERIMENTAL
Drug: Medium dose of BIBR 277

High dose of BIBR 277

EXPERIMENTAL
Drug: High dose of BIBR 277

Interventions

Low dose of BIBR 277DRUG
Low dose of BIBR 277
Medium dose of BIBR 277DRUG
Medium dose of BIBR 277
High dose of BIBR 277DRUG
High dose of BIBR 277

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

June 1, 1998

Primary Completion

September 1, 1998

Last Updated

July 11, 2014

Record last verified: 2014-07