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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121518
• Other study ID #: A30_17HT2222
• Status: Completed
• Phase: Phase 3
• Start date: July 31, 2023
• Est. completion date: March 26, 2024

Study information

• Verified date: April 2024
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: March 26, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• D064 and D702, QD
Experimental Group Subjects assigned to this group are treated with D064, D702
• D064 and Placebo of D702, QD
Comparator Group Subjects assigned to this group are treated with D064, placebo of D702
• Placebo of D064 and D702, QD
Comparator Group Subjects assigned to this group are treated with D702, placebo of D064

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul	Seongdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))	Compare experimental group with comparator group	8 weeks