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Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Primary Purpose

Essential Hypertension

Status

Recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

D064, D701, placebo of D012

D012, placebo of D064, placebo of D701

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who are 19 years old or older.
Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

Subjects with a history of secondary hypertension or suspected secondary hypertension
Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
Subjects who received other clinical trial drugs within 4 weeks of screening visit.
Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Comparator Group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in MSSBP

Compare experimental group with comparator group

Secondary Outcome Measures

Full Information

NCT ID

NCT05526703

First Posted

August 31, 2022

Last Updated

November 25, 2022

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT05526703

Brief Title

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Official Title

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Title

Comparator Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

D064, D701, placebo of D012

Other Intervention Name(s)

D064, D701 are consisted of antihypertensive agent.

Intervention Description

Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012

Intervention Type

Drug

Intervention Name(s)

D012, placebo of D064, placebo of D701

Other Intervention Name(s)

D012 is consisted of antihypertensive agent.

Intervention Description

Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701

Primary Outcome Measure Information:

Title

Change from baseline in MSSBP

Description

Compare experimental group with comparator group

Time Frame

8 weeks after drug administrations

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who are 19 years old or older. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF. Exclusion Criteria: Subjects with a history of secondary hypertension or suspected secondary hypertension Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period Subjects with hypersensitivity or history of clinical trial drugs and similar drugs Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening Subjects who received other clinical trial drugs within 4 weeks of screening visit. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yeonhwa Park, Project Leader

Phone

82-2-6373-0636

yeonhwa@ckdpharm.com

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

ASI|KR|KS013|SEOUL

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung Hyuk Choi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

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