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

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00937651
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 10, 2009
July 10, 2009
April 2005
June 2006   (final data collection date for primary outcome measure)
the level of sitting diastolic blood pressure reduction [ Time Frame: Day -1 vs Day 27 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 [ Time Frame: Day -1 vs Day 27 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)
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

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.

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.

Approximately 60 patients will be enrolled over 12 months in Seoul National University Hospital.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 180 mg

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Placebo
    Placebo
  • Drug: Fimasartan (BR-A-657•K) 20 mg
    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
    Other Name: Fimasartan
  • Drug: Fimasartan (BR-A-657•K) 60 mg
    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
    Other Name: Fimasartan
  • Drug: Fimasartan (BR-A-657•K) 180 mg
    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
    Other Name: Fimasartan
  • Placebo Comparator: Placebo
    Placebo, 3 tablets
    Intervention: Drug: Placebo
  • Active Comparator: BR-A-657•K 20 mg group
    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets
    Intervention: Drug: Fimasartan (BR-A-657•K) 20 mg
  • Active Comparator: BR-A-657•K 60 mg group
    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
    Intervention: Drug: Fimasartan (BR-A-657•K) 60 mg
  • Active Comparator: BR-A-657•K 180 mg group
    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
    Intervention: Drug: Fimasartan (BR-A-657•K) 180 mg
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. Erratum in: Clin Ther. 2012 Sep;34(9):2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
  2. Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
  3. Patients with secondary hypertension
  4. Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
  5. Patients with symptoms of orthostatic hypotension
  6. Patients with severe insulin dependent diabetes or uncontrolled diabetes
  7. 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
  8. Patients with consumption disease, autoimmune disease, or connective tissue disease
  9. Patients with the history of type B hepatitis or type C hepatitis
  10. Patients with HIV infection or hepatitis
  11. Patients with clinically significant abnormal laboratory test findings
  12. Patients on any drug treatment that might affect the blood pressure
  13. Patients with allergy or contraindication to angiotensin II-receptor antagonists
  14. Patients with current or suspected alcohol addiction or history of drug abuse
  15. Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table
  16. Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00937651
A657-BR-CT-201
Yes
Choi, Jeongeun / Director, Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP