NCT00937534

Brief Summary

The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 4, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

July 6, 2009

Last Update Submit

November 2, 2009

Conditions

Essential Hypertension

Keywords

Fimasartanhealthy elderly and young male volunteerpharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • Cmax, AUClast, tmax, t1/2

    0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h

Study Arms (2)

Part A

ACTIVE COMPARATOR

Young male healthy volunteer

Drug: Fimasartan

Part B

ACTIVE COMPARATOR

Elderly male healthy volunteer

Drug: Fimasartan

Interventions

FimasartanDRUG

Fimasartan 240mg/day

Part APart B

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • young: 19-45 years
  • elderly: more than 65 years
  • sex: male
  • body weight: greater than 55 kg

You may not qualify if:

  • patients with contraindication to angiotensin II receptor antagonist.
  • patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
  • patients with history or diseases which might affect absorption of the drug
  • patients with HIV, type B or C hepatitis
  • smokers of 20 or more cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 13, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-11