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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06121518
Collaborator
(none)
228
Enrollment
1
Location
3
Arms
14
Anticipated Duration (Months)
16.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Condition or Disease Intervention/Treatment Phase
  • Drug: D064 and D702, QD
  • Drug: D064 and Placebo of D702, QD
  • Drug: Placebo of D064 and D702, QD
 Phase 3

Detailed Description

This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Study Design

Study Type:
Interventional
Anticipated Enrollment :
228 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 D064 or D702 Monotherapy in Essential Hypertension Patients
Actual Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Jun 28, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

D064 and D702 Combination Therapy

Drug: D064 and D702, QD
Experimental Group Subjects assigned to this group are treated with D064, D702
Other Names:
  • D064 and D702 Combination Therapy

    		•
    Active Comparator: Comparator Group 1

    D064 Monotherapy

    Drug: D064 and Placebo of D702, QD
    Comparator Group Subjects assigned to this group are treated with D064, placebo of D702
    Other Names:
  • D064 Monotherapy

    		•
    Active Comparator: Comparator Group 2

    D702 Monotherapy

    Drug: Placebo of D064 and D702, QD
    Comparator Group Subjects assigned to this group are treated with D702, placebo of D064
    Other Names:
  • D702 Monotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in MSSBP(mean sitting SBP) [8 weeks]

      Compare experimental group with comparator group

    Eligibility Criteria

    Criteria

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

    1. Subjects who are 19 years old or older.

    2. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:

    • Didn't take antihypertensive drug

    • 140 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg

    • Taking antihypertensive drug

    • 130 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg

    1. 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 symptomatic orthostatic hypotension

    3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c > 9.0%)

    4. Subjects with Severe heart failure(NYHA Class 3,4) etc.,

    5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening

    6. Subjects with a history of disability to investigational product ADME at the time of screening

    7. Subjects with abnormalities in laboratory test results at the time of screening

    8. Subjects with hypersensitivity or history of investigational product and similar drugs

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

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

    11. Subjects who received other investigational product within 4 weeks of screening visit

    12. 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 investigational product

    13. 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 Hanyang University Seoul Hospital Seoul Seongdong-gu Korea, Republic of 04763

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Jinho Shin, M.D, Ph.D, Hanyang University Seoul Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT06121518
    Other Study ID Numbers:
    • A30_17HT2222
    First Posted:
    Nov 8, 2023
    Last Update Posted:
    Nov 8, 2023
    Last Verified:
    Nov 1, 2023
    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
    Verapamil

    Study Results

    No Results Posted as of Nov 8, 2023