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

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

The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: D064 and D702, QD; Drug: D064 and Placebo of D702, QD; Drug: Placebo of D064 and D702, QD

Detailed Description

This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongdong-gu
    • Seoul, Seongdong-gu, Korea, Republic of, 04763
      • Hanyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Subjects who are 19 years old or older.

2. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:

   • Didn't take antihypertensive drug

     • 140 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg

   • Taking antihypertensive drug

     • 130 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg
3. 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 symptomatic orthostatic hypotension
3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c > 9.0%)
4. Subjects with Severe heart failure(NYHA Class 3,4) etc.,
5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
6. Subjects with a history of disability to investigational product ADME at the time of screening
7. Subjects with abnormalities in laboratory test results at the time of screening
8. Subjects with hypersensitivity or history of investigational product and similar drugs
9. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
11. Subjects who received other investigational product within 4 weeks of screening visit
12. 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 investigational product
13. 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; D064 and D702 Combination Therapy	Drug: D064 and D702, QD; Experimental Group Subjects assigned to this group are treated with D064, D702; Other Names: D064 and D702 Combination Therapy
Active Comparator: Comparator Group 1; D064 Monotherapy	Drug: D064 and Placebo of D702, QD; Comparator Group Subjects assigned to this group are treated with D064, placebo of D702; Other Names: D064 Monotherapy
Active Comparator: Comparator Group 2; D702 Monotherapy	Drug: Placebo of D064 and D702, QD; Comparator Group Subjects assigned to this group are treated with D702, placebo of D064; Other Names: D702 Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))	Compare experimental group with comparator group	8 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jinho Shin, M.D, Ph.D, Hanyang University Seoul Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: A30_17HT2222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No