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Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)

NCT00937651 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2009-07-13

No results posted yet for this study

Summary

Study objective:

1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20\~180mg for 4 weeks to patients with essential hypertension.
2. To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20\~180mg for 4 weeks to patients with essential hypertension.
3. To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.

Conditions

  • Essential Hypertension

Interventions

DRUG

Placebo

Placebo

DRUG

Fimasartan (BR-A-657•K) 20 mg

Fimasartan 20 mg, 1 tablet + placebo, 2 tablets

DRUG

Fimasartan (BR-A-657•K) 60 mg

Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet

DRUG

Fimasartan (BR-A-657•K) 180 mg

Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-06-30
Completion
2006-06-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937651 on ClinicalTrials.gov