A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy

Essential Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Controlled by Fimasartan 60mg(Phase 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258673
• Other study ID #: BR-FHC-CT-301
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2010
• Last updated: January 2, 2012
• Start date: November 2010

Study information

• Verified date: December 2010
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female outpatients 18 years of age and older

• Patients with antihypertensive agents at screening: DBP<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg~120mmHg

• 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

• Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg~109mmHg and SBP<180mmHg

Exclusion Criteria:

• The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension

• Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit

• 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 12weeks, 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(include carrier)

• 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 participated other clinical trial 12 weeks before Screening - Patients judged to be inappropriate for this study by the investigator with other reasons

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Fimasartan/HCTZ combination
Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg
• Fimasartan
Fimasartan 60mg, 120mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Bundang	Sungnam

Sponsors (19)

Lead Sponsor

Collaborator

Boryung Pharmaceutical Co., Ltd

Ajou University, Asan Medical Center, Cheil General Hospital and Women’s Healthcare Center, Chonbuk National University Hospital, Chonnam National University Hospital, DongGuk University, Gangnam Severance Hospital, Hanyang University, Ilsan-Paik Hospital, Korea University Guro Hospital, Kyung-Hee University Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital, SMG-SNU Boramae Medical Center, The Catholic University of Korea, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic Blood Pressure		4week	No
Secondary	Systolic Blood Pressure / Diastolic Blood Pressure		4week, 8week / 8week	No