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

November 25, 2022 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, ASI|KR|KS013|SEOUL
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Seung Hyuk Choi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Drug: D064, D701, placebo of D012
Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012
Other Names:
  • D064, D701 are consisted of antihypertensive agent.
Active Comparator: Comparator Group
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
Other Names:
  • D012 is consisted of antihypertensive agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MSSBP
Time Frame: 8 weeks after drug administrations
Compare experimental group with comparator group
8 weeks after drug administrations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A30_14HT2209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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