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

NCT ID: NCT05931224

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2024-05-13

Brief Summary

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

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Group

Group Type EXPERIMENTAL

D064, D702, placebo of D660

Intervention Type DRUG

Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660

Comparator Group

Group Type EXPERIMENTAL

D660, placebo of D064, placebo of D702

Intervention Type DRUG

Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702

Interventions

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D064, D702, placebo of D660

Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660

Intervention Type DRUG

D660, placebo of D064, placebo of D702

Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702

Intervention Type DRUG

Other Intervention Names

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D064, D702 are consisted of antihypertensive agent. D660 is consisted of antihypertensive agent.

Eligibility Criteria

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Inclusion Criteria

* Subjects who are 19 years old or older.
* 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 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inho Chae, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Bundang-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A30_15HT2213

Identifier Type: -

Identifier Source: org_study_id

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