Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)
Fimasartan
Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension
1 other identifier
interventional
81
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
Shorter than P25 for phase_2
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
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedJuly 13, 2009
July 1, 2009
1.2 years
July 10, 2009
July 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the level of sitting diastolic blood pressure reduction
Day -1 vs Day 27
Secondary Outcomes (1)
the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring
Day -1 vs Day 27
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo, 3 tablets
BR-A-657•K 20 mg group
ACTIVE COMPARATORFimasartan 20 mg, 1 tablet + placebo, 2 tablets
BR-A-657•K 60 mg group
ACTIVE COMPARATORFimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
BR-A-657•K 180 mg group
ACTIVE COMPARATORFimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Interventions
Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Eligibility Criteria
You may qualify if:
- Adult men and women, aged 18 - 65
- Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
- Patients who gave their consent to participate in this study and signed the written informed consent form
- Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date
You may not qualify if:
- Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
- Patients whose sitting DBP is \< 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
- Patients with secondary hypertension
- Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
- Patients with symptoms of orthostatic hypotension
- Patients with severe insulin dependent diabetes or uncontrolled diabetes
- Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
- Patients with consumption disease, autoimmune disease, or connective tissue disease
- Patients with the history of type B hepatitis or type C hepatitis
- Patients with HIV infection or hepatitis
- Patients with clinically significant abnormal laboratory test findings
- Patients on any drug treatment that might affect the blood pressure
- Patients with allergy or contraindication to angiotensin II-receptor antagonists
- Patients with current or suspected alcohol addiction or history of drug abuse
- Patients whose mean weight lies out of the range of -15% \~ +35%, based on the Modified Metropolitan Life Insurance table
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, Jeon ES, Ha JW, Rim SJ, Park JB, Shin JH, Oh BH. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean Patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012 Jun;34(6):1273-89. doi: 10.1016/j.clinthera.2012.04.021. Epub 2012 May 17.
PMID: 22608107DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
April 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
July 13, 2009
Record last verified: 2009-07