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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: D064, D702, placebo of D660; Drug: D660, placebo of D064, placebo of D702

• Registration Number: NCT05931224
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study Start: 2023-06-28
• Study First Posted: 2023-07-05
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Subjects who are 19 years old or older.
• Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	D064, D702, placebo of D660	-
Comparator Group	D660, placebo of D064, placebo of D702	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in MSSBP	8 weeks after drug administrations	MSSBP(Mean Sitting Systolic Blood Pressure)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of