A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide

NCT ID: NCT02222480

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg

Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Fimasartan 60 mg, Hydrochlorothiazide 25 mg

Combination of Fimasartan/Hydrochlorothiazide 60/25mg

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg

Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Fimasartan 120 mg, Hydrochlorothiazide 25 mg

Combination of Fimasartan/Hydrochlorothiazide 120/25mg

Group Type: EXPERIMENTAL

Fimasartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Fimasartan

Intervention Type: DRUG

Hydrochlorothiazide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects of no childbearing potential 19-70 years of age

2. Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive medications (no wash-out is needed for those not on any antihypertensive medications) with a difference of ≤10 mmHg in sitting DBP between before and after run-in

3. Subjects who agree to participate in this study and give written informed consent

4. Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion Criteria

1. Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg

2. Orthostatic hypotension with clinically significant signs or symptoms

3. Secondary hypertension

4. Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period

5. Clinically significant abnormal laboratory test results, e.g., serum creatinine >1.5 times upper limit of normal, AST, ALT > 2 times upper limit of normal

6. Conditions that may affect to absorption, distribution, metabolism, and excretion for the study drugs

7. Severe insulin-dependent or uncontrolled diabetes mellitus (HbA1c >9%, increased dose of an oral hypoglycemic agent within 12 weeks before screening, or active insulin treatment at screening)

8. Severe cardiovascular diseases within 6 months of screening including ischemic heart disease, peripheral vascular disease, significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease, severe cerebrovascular disease

9. History of percutaneous transluminal coronary angiography or coronary artery bypass graft

10. Chronic debilitating disease, autoimmune disease, connective tissue disease

11. Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-HIV antibody

12. History or evidence of alcohol or drug abuse within 2 years

13. Known allergic reaction to any angiotensin receptor blockers

14. Chronic inflammation disease requiring chronic anti-inflammation therapy

15. Women of childbearing potential without any contraceptive measure or breast-feeding mother

16. Prior participation in a clinical trial of any investigational products within 12 weeks from screening

17. Serum potassium <3.5 mmol/L or >5.5 mmol/L at any time of the study period

18. Depletion of sodium ion or body fluid, which cannot be corrected easily during the study period

19. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

20. Considered unsuitable to participate in the study under the discretion of the principal investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FHC-CT-201-BZ

Identifier Type: -

Identifier Source: org_study_id