Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Phase 3

Recruiting

• Conditions: Essential Hypertension
• Interventions: Drug: D012, placebo of D064, placebo of D701; Drug: D064, D701, placebo of D012

• Registration Number: NCT05526703
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Study Start: 2022-09-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-28
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Subjects who are 19 years old or older.
2. 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 who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
3. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
4. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
5. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
6. Subjects who received other clinical trial drugs within 4 weeks of screening visit.
7. 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
8. 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
Comparator Group	D012, placebo of D064, placebo of D701	-
Experimental Group	D064, D701, placebo of D012	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in MSSBP	8 weeks after drug administrations	Compare experimental group with comparator group

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of