Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

NCT00923611 | Completed Phase 2 DMC

• 1 other identifier: A-657-BR-CT-202
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.

Conditions

Hypertension

Keywords

Hypertension; Fimasartan

Outcome Measures

Primary Outcomes (1)

• change from baseline to end of 8 week treatment in sitting diastolic blood pressure

  8 week from baseline

Secondary Outcomes (3)

• change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure

  2, 4 week from baseline

• change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure

  2,4,8 week from baseline

• responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg

  8 week from baseline

Study Arms (5)

Placebo

PLACEBO COMPARATOR

3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks

Drug: Fimasartan

Fimasartan 20mg

ACTIVE COMPARATOR

2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks

Drug: Fimasartan

Fimasartan 60mg

ACTIVE COMPARATOR

3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks

Drug: Fimasartan

Fimasartan 120mg

ACTIVE COMPARATOR

3 tablets of fimasartan 40mg will be taken 30minutes after breakfast

Drug: Fimasartan

Fimasartan 240mg

ACTIVE COMPARATOR

3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks

Drug: Fimasartan

Interventions

Fimasartan DRUG

Fimasartan 120mg; Fimasartan 20mg; Fimasartan 240mg; Fimasartan 60mg; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Screening and Baseline(Day1) are 95\~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) is under 7mmHg.
• Subjects who agree to participate in this sudy and give written informed consent
• Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

You may not qualify if:

• The sitting DBP is less than 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg
• Patients with secondary hypertension
• Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
• Patients with postural hypotension
• Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c\>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening)
• Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
• Patients with consumptive disease, autoimmune disease, connective tissue disease
• Patients with a history of type B or C hepatitis
• Patients with HIV or hepatitis
• Patients with clinically significant laboratory abnormality
• Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
• Patients with allergy or contraindication to any angiotensin II receptor antagonists
• Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
• Patients judged to have a history of alcohol or drug abuse by the investigator
• Patients with average weight \> +35% or \<-15% in Modified Metropolitan Life Insurance table

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Seoul National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• The Catholic University of Korea: collaborator
• Severance Hospital: collaborator
• Yonsei University: collaborator
• Cheil General Hospital and Women's Healthcare Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

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: 22608107 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Byung-Hee Oh, Professor

  Seoul National University Hospital

  STUDY CHAIR

• Jae-Joong Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Eun-Suk Jeon, Professor

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Dong-Ju Choi, Professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Ki-Bae Seong, Professor

  Kangnam ST.Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Jong-Won Ha, Professor

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Se-Joong Lim, Professor

  Yonsei University

  PRINCIPAL INVESTIGATOR

• Jeong-Bae Park, Professor

  Cheil General Hospital and Women's Healthcare Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 18, 2009

Record last verified: 2009-06

Locations

KR (1)