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

NCT02222480 | Completed Phase 2

• 1 other identifier: BR-FHC-CT-201-BZ
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Keywords

Patients; with mild; moderate; essential

Outcome Measures

Primary Outcomes (1)

• Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)

  from baseline to 2 weeks

Study Arms (5)

Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg

EXPERIMENTAL

Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg

Drug: Fimasartan; Drug: Hydrochlorothiazide

Fimasartan 60 mg, Hydrochlorothiazide 25 mg

EXPERIMENTAL

Combination of Fimasartan/Hydrochlorothiazide 60/25mg

Drug: Fimasartan; Drug: Hydrochlorothiazide

Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg

EXPERIMENTAL

Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg

Drug: Fimasartan; Drug: Hydrochlorothiazide

Fimasartan 120 mg, Hydrochlorothiazide 25 mg

EXPERIMENTAL

Combination of Fimasartan/Hydrochlorothiazide 120/25mg

Drug: Fimasartan; Drug: Hydrochlorothiazide

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Fimasartan DRUG

Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg; Fimasartan 120 mg, Hydrochlorothiazide 25 mg; Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg; Fimasartan 60 mg, Hydrochlorothiazide 25 mg

Hydrochlorothiazide DRUG

Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg; Fimasartan 120 mg, Hydrochlorothiazide 25 mg; Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg; Fimasartan 60 mg, Hydrochlorothiazide 25 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects of no childbearing potential 19-70 years of age
• 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
• Subjects who agree to participate in this study 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:

• Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg
• Orthostatic hypotension with clinically significant signs or symptoms
• Secondary hypertension
• Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period
• 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
• Conditions that may affect to absorption, distribution, metabolism, and excretion for the study drugs
• 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)
• 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
• History of percutaneous transluminal coronary angiography or coronary artery bypass graft
• Chronic debilitating disease, autoimmune disease, connective tissue disease
• Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-HIV antibody
• History or evidence of alcohol or drug abuse within 2 years
• Known allergic reaction to any angiotensin receptor blockers
• Chronic inflammation disease requiring chronic anti-inflammation therapy
• Women of childbearing potential without any contraceptive measure or breast-feeding mother

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Hypertension; Lymphoma, Follicular

Interventions

fimasartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

KR (1)