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

NCT ID: NCT06121518

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-03-26

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

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

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

D064 and D702 Combination Therapy

Group Type: EXPERIMENTAL

D064 and D702, QD

Intervention Type: DRUG

Experimental Group Subjects assigned to this group are treated with D064, D702

Comparator Group 1

D064 Monotherapy

Group Type: ACTIVE_COMPARATOR

D064 and Placebo of D702, QD

Intervention Type: DRUG

Comparator Group Subjects assigned to this group are treated with D064, placebo of D702

Comparator Group 2

D702 Monotherapy

Group Type: ACTIVE_COMPARATOR

Placebo of D064 and D702, QD

Intervention Type: DRUG

Comparator Group Subjects assigned to this group are treated with D702, placebo of D064

Interventions

D064 and D702, QD

Experimental Group Subjects assigned to this group are treated with D064, D702

Intervention Type: DRUG

D064 and Placebo of D702, QD

Comparator Group Subjects assigned to this group are treated with D064, placebo of D702

Intervention Type: DRUG

Placebo of D064 and D702, QD

Comparator Group Subjects assigned to this group are treated with D702, placebo of D064

Intervention Type: DRUG

Other Intervention Names

D064 and D702 Combination Therapy; D064 Monotherapy; D702 Monotherapy

Eligibility Criteria

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

3. 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinho Shin, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hanyang University Seoul Hospital

Locations

Hanyang University Seoul Hospital

Seoul, Seongdong-gu, South Korea

Countries

South Korea

Other Identifiers

A30_17HT2222

Identifier Type: -

Identifier Source: org_study_id