NCT01518998

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Aug 2011

Typical duration for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

January 24, 2012

Last Update Submit

June 29, 2016

Conditions

Hypertension

Keywords

FimasartanAmlodipineantihypertension

Outcome Measures

Primary Outcomes (1)

  • Sitting Diastolic Blood Pressure

    To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit

    8weeks from baseline visit

Secondary Outcomes (3)

  • Sitting Systolic Blood Pressure

    at 4 and 8 weeks from Baseline visit

  • Sitting Diastolic Blood Pressure

    4weeks from baseline visit

  • Responder ratio

    at 8weeks from baseline visit

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Take one double-blind capsule filled with a placebo tablet in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg

ACTIVE COMPARATOR

Take one double-blind capsule filled with of Fimasartan 60mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg

ACTIVE COMPARATOR

Take one double-blind capsule filled with Fimasartan 30mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Amlodipine 5mg

ACTIVE COMPARATOR

Take one double-blind capsule filled with Amlodipine 5mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Amlodipine 10mg

ACTIVE COMPARATOR

Take one double-blind capsule filled with Amlodipine 10mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg/ Amlodipine 5mg

EXPERIMENTAL

Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 60mg/Amlodipine 10mg

EXPERIMENTAL

Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg/Amlodipine 5mg

EXPERIMENTAL

Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Fimasartan 30mg/Amlodipine 10mg

EXPERIMENTAL

Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning

Drug: Fimasartan , Amlodipine, Placebo

Interventions

Fimasartan , Amlodipine, PlaceboDRUG

Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination

Also known as: Kanarb, Norvasc
Amlodipine 10mgAmlodipine 5mgFimasartan 30mgFimasartan 30mg/Amlodipine 10mgFimasartan 30mg/Amlodipine 5mgFimasartan 60mgFimasartan 60mg/ Amlodipine 5mgFimasartan 60mg/Amlodipine 10mgPlacebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who agreed to participate in this study and submitted the written informed consent
  • Subjects aged 20 to 75 years
  • Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
  • Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

You may not qualify if:

  • Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
  • Patients with secondary hypertension
  • Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
  • Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
  • Patients with sodium ion or body fluid is depleted and not able to correct
  • Patients with hypotension who has sign and symptom
  • Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
  • Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, regimen change of oral hypoglycemic agent, using insulin)
  • Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
  • Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  • Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  • Patients with severe cerebrovascular disease
  • Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
  • Patients with known severe or malignancy retinopathy
  • Patients with hepatitis B or C or HIV positive reaction
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, South Korea

Location

Related Publications (1)

  • Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4.

    PMID: 25850881DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

fimasartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Young Kwan Jeon, Medical Director

    Boryung Pharmaceutical Co., Ltd

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

KR(1)