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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05931224
Collaborator
(none)
338
Enrollment
1
Location
2
Arms
1.8
Anticipated Duration (Months)
183.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: D064, D702, placebo of D660
  • Drug: D660, placebo of D064, placebo of D702
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 28, 2023
Anticipated Primary Completion Date :
Aug 23, 2023
Anticipated Study Completion Date :
Aug 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Drug: D064, D702, placebo of D660
Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660
Other Names:
  • D064, D702 are consisted of antihypertensive agent.

    		•
    Experimental: Comparator Group

    Drug: D660, placebo of D064, placebo of D702
    Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702
    Other Names:
  • D660 is consisted of antihypertensive agent.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in MSSBP [8 weeks after drug administrations]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Subjects with a history of secondary hypertension or suspected secondary hypertension

    2. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs

    3. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period

    4. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening

    5. Subjects who received other clinical trial drugs within 4 weeks of screening visit.

    6. 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

    7. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Bundang-gu Korea, Republic of 13620

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Inho Chae, M.D, Ph.D, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05931224
    Other Study ID Numbers:
    • A30_15HT2213
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Antihypertensive Agents

    Study Results

    No Results Posted as of Jul 5, 2023