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

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 D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526703
• Other study ID #: A30_14HT2209
• Status: Recruiting
• Phase: Phase 3
• Start date: September 28, 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: Yeonhwa Park, Project Leader
• Phone: 82-2-6373-0636
• Email: yeonhwa[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• 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 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

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	Compare experimental group with comparator group	8 weeks after drug administrations