A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-09-30

Brief Summary

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A phase 3 study to evaluate efficacy and safety of HCP1401

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Detailed Description

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A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

HCP1401

Group Type EXPERIMENTAL

HCP1401

Intervention Type DRUG

amlodipine, Losartan, Chlorthalidone FDC

Reference

HCP0605

Group Type ACTIVE_COMPARATOR

HCP0605

Intervention Type DRUG

amlodipine, Losartan FDC

Interventions

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HCP1401

amlodipine, Losartan, Chlorthalidone FDC

Intervention Type DRUG

HCP0605

amlodipine, Losartan FDC

Intervention Type DRUG

Other Intervention Names

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amlodipine, Losartan, Chlorthalidone amlodipine, Losartan

Eligibility Criteria

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Inclusion Criteria

* Hypertension patient who satisfied below condition at Visit 1.

* patient who takes antihypertensive drug

* 140mmHg \<= sitSBP \<= 200mmHg
* patient who doesn't take antihypertensive drug

* 160mmHg \<= sitSBP \<= 200mmHg
* 140mmHg \<= sitSBP \<= 200mmHg at Visit 2

Exclusion Criteria

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 2
* Patient with secondary hypertension

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No