Back to resultsClinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
Primary Purpose
Essential Hypertension
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D064, D702, placebo of D660
D660, placebo of D064, placebo of D702
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
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.
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental Group
Comparator Group
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in MSSBP
Secondary Outcome Measures
Full Information
NCT ID
NCT05931224
First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05931224
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
Official Title
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D660 Monotherapy in Essential Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Anticipated)
Primary Completion Date
August 23, 2023 (Anticipated)
Study Completion Date
August 23, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 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
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Comparator Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
D064, D702, placebo of D660
Other Intervention Name(s)
D064, D702 are consisted of antihypertensive agent.
Intervention Description
Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660
Intervention Type
Drug
Intervention Name(s)
D660, placebo of D064, placebo of D702
Other Intervention Name(s)
D660 is consisted of antihypertensive agent.
Intervention Description
Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702
Primary Outcome Measure Information:
Title
Change from baseline in MSSBP
Time Frame
8 weeks after drug administrations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inho Chae, M.D, Ph.D
Phone
+82-31-787-7012
Email
ihchae@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inho Chae, M.D, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inho Chae
Phone
+82-31-787-7012
Email
ihchae@snubh.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
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