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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: D064 and D702, QD; Drug: D064 and Placebo of D702, QD; Drug: Placebo of D064 and D702, QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06121518

A30_17HT2222

Details and patient eligibility

About

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

Full 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

Enrollment: 235 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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235 participants in 3 patient groups

Experimental Group

Experimental group

Description:

D064 and D702 Combination Therapy

Treatment:

Drug: D064 and D702, QD

Comparator Group 1

Active Comparator group

Description:

D064 Monotherapy

Treatment:

Drug: D064 and Placebo of D702, QD

Comparator Group 2

Active Comparator group

Description:

D702 Monotherapy

Treatment:

Drug: Placebo of D064 and D702, QD