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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: HCP1401; Drug: HCP0605

Study type: Interventional

Funder types: Industry

Identifiers

NCT02916602

HM-ALCH-301

Details and patient eligibility

About

A phase 3 study to evaluate efficacy and safety of HCP1401

Full description

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

Enrollment: 340 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups

Treatment

Experimental group

Description:

HCP1401

Treatment:

Drug: HCP1401

Reference

Active Comparator group

Description:

HCP0605

Treatment:

Drug: HCP0605