Clinical Trial to Evaluate the Efficacy and Safety of D06... | NCT05931224

Studies
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy

NCT05931224

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Jun 4, 2024Actual

Enrollment

346Actual

Phase

Phase 3

Conditions

Essential Hypertension

Interventions

D064, D702, placebo of D660
D660, placebo of D064, placebo of D702

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2023Actual

Primary Completion Date

May 13, 2024Actual

Completion Date

May 13, 2024Actual

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2024

Last Update Posted Date

Jun 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

346Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental		Drug: D064, D702, placebo of D660
Comparator Group	Experimental		Drug: D660, placebo of D064, placebo of D702

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D064, D702, placebo of D660	Drug	Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660	Experimental Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in MSSBP	MSSBP(Mean Sitting Systolic Blood Pressure)	8 weeks after drug administrations

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Inho Chae, M.D, Ph.D	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Bundang-gu	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C482243	2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided