Essential Hypertension Clinical Trial
Official title:
Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension
Study objective:
1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after
the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with
essential hypertension.
2. To review the pharmacokinetic profile after the multiple administration and the
pharmacodynamic profile regarding the renin-angiotensin system, after the oral
administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential
hypertension.
3. To determine the dose for the clinical study at the next phase by analyzing the
relationship between the antihypertensive efficacy and pharmacokinetic •
pharmacodynamic results.
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan
(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the
Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan
(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was
safe and tolerable though one temporal adverse event was observed in high dose.
A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be
conducted to evaluate the antihypertensive efficacy and tolerability and to determine
adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate
essential hypertension.
Approximately 60 patients will be enrolled over 12 months in Seoul National University
Hospital.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If
subjects take any antihypertensive medications before screening, the subjects will have 1
week of wash-out period.
Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV :
Fimasartan 180 mg
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03708601 -
Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
|
||
| Not yet recruiting |
NCT05503953 -
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
|
Phase 3 | |
| Recruiting |
NCT05526703 -
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy
|
Phase 3 | |
| Completed |
NCT06395194 -
Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension
|
Phase 3 | |
| Not yet recruiting |
NCT06418074 -
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity
|
N/A | |
| Completed |
NCT02890173 -
Study of CS-3150 in Patients With Essential Hypertension
|
Phase 3 | |
| Withdrawn |
NCT02096939 -
Microvascular Function in Primary Aldosteronism
|
N/A | |
| Completed |
NCT02944734 -
Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
|
Phase 2 | |
| Recruiting |
NCT01956786 -
Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
|
Phase 2/Phase 3 | |
| Completed |
NCT02553512 -
Helius in Hypertension-I: The UK Hypertension Registry
|
N/A | |
| Completed |
NCT01198249 -
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
|
Phase 1 | |
| Completed |
NCT01001572 -
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
|
Phase 3 | |
| Recruiting |
NCT00380289 -
Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
|
N/A | |
| Completed |
NCT00139698 -
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
|
Phase 3 | |
| Completed |
NCT00288184 -
Uric Acid in Essential Hypertension in Children
|
Phase 2 | |
| Completed |
NCT01289886 -
Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06041529 -
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension
|
Phase 4 | |
| Completed |
NCT04470830 -
A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
|
||
| Completed |
NCT00758524 -
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
|
Phase 2 | |
| Recruiting |
NCT05109013 -
Juvenile Essential Arterial Hypertension and Vascular Function
|