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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02222480
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Fimasartan Drug: Hydrochlorothiazide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg
Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg
Drug: Fimasartan
Drug: Hydrochlorothiazide
Experimental: Fimasartan 60 mg, Hydrochlorothiazide 25 mg
Combination of Fimasartan/Hydrochlorothiazide 60/25mg
Drug: Fimasartan
Drug: Hydrochlorothiazide
Experimental: Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg
Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg
Drug: Fimasartan
Drug: Hydrochlorothiazide
Experimental: Fimasartan 120 mg, Hydrochlorothiazide 25 mg
Combination of Fimasartan/Hydrochlorothiazide 120/25mg
Drug: Fimasartan
Drug: Hydrochlorothiazide
Placebo Comparator: Placebo
placebo
Drug: Placebo



Primary Outcome Measures :
  1. Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM) [ Time Frame: from baseline to 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222480


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital

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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02222480     History of Changes
Other Study ID Numbers: BR-FHC-CT-201-BZ
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Patients
with mild
moderate
essential
Additional relevant MeSH terms:
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Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action