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

Last updated: April 3, 2024
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

High Blood Pressure (Hypertension)

Circulation Disorders

Treatment

D064 and D702, QD

Placebo of D064 and D702, QD

D064 and Placebo of D702, QD

Clinical Study ID

NCT06121518
A30_17HT2222
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 armmeets 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 signedICF.

Exclusion

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 ofscreening
  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 inthis plan during the clinical trial participation period
  10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeksas 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 appropriatecontraception during the clinical trial period and for two weeks after the end ofadministration of the last investigational product
  13. Subjects who are unable to participate in this clinical trial at the discretion of theinvestigator

Study Design

Total Participants: 235
Treatment Group(s): 3
Primary Treatment: D064 and D702, QD
Phase: 3
Study Start date:
July 31, 2023
Estimated Completion Date:
March 26, 2024

Study 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

Connect with a study center

  • Hanyang University Seoul Hospital

    Seoul, Seongdong-gu 04763
    Korea, Republic of

    Site Not Available

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