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

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D660 Monotherapy in Essential Hypertension Patients

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: D064, D702, placebo of D660; Drug: D660, placebo of D064, placebo of D702

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam, Bundang-gu, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Drug: D064, D702, placebo of D660; Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660; Other Names: D064, D702 are consisted of antihypertensive agent.
Experimental: Comparator Group	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; Other Names: D660 is consisted of antihypertensive agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in MSSBP	MSSBP(Mean Sitting Systolic Blood Pressure)	8 weeks after drug administrations

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Inho Chae, M.D, Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): May 13, 2024
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Antihypertensive Agents
• Other Study ID Numbers: A30_15HT2213

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