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

NCT ID: NCT05526703

Last Updated: 2022-11-28

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2023-10-31

Brief Summary

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Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 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, D701, placebo of D012

Intervention Type DRUG

Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012

Comparator Group

Group Type ACTIVE_COMPARATOR

D012, placebo of D064, placebo of D701

Intervention Type DRUG

Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701

Interventions

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D064, D701, placebo of D012

Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012

Intervention Type DRUG

D012, placebo of D064, placebo of D701

Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701

Intervention Type DRUG

Other Intervention Names

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D064, D701 are consisted of antihypertensive agent. D012 is consisted of antihypertensive agent.

Eligibility Criteria

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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.

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.
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

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeonhwa Park, Project Leader

Role: CONTACT

82-2-6373-0636

Facility Contacts

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Seung Hyuk Choi

Role: primary

Other Identifiers

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A30_14HT2209

Identifier Type: -

Identifier Source: org_study_id

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