A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
Information source: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Fimasartan (Drug); Hydrochlorothiazide (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Boryung Pharmaceutical Co., Ltd Overall contact: Joo-Hyun Song, Phone: 82-2-708-8053, Email: jsong@boryung.co.kr
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
Clinical Details
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 design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
Eligibility
Minimum age: 19 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Joo-Hyun Song, Phone: 82-2-708-8053, Email: jsong@boryung.co.kr
Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting Howard Lee, MD, Ph.D, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: October 15, 2014
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