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

NCT05931224 | Completed Phase 3

• 1 other identifier: A30_15HT2213
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MSSBP

  MSSBP(Mean Sitting Systolic Blood Pressure)

  8 weeks after drug administrations

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: D064, D702, placebo of D660

Comparator Group

EXPERIMENTAL

Drug: D660, placebo of D064, placebo of D702

Interventions

D064, D702, placebo of D660 DRUG

Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660

Also known as: D064, D702 are consisted of antihypertensive agent.

Experimental Group

D660, placebo of D064, placebo of D702 DRUG

Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702

Also known as: D660 is consisted of antihypertensive agent.

Comparator Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are 19 years old or older.
• Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

You may not qualify if:

• Subjects with a history of secondary hypertension or suspected secondary hypertension
• Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
• Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
• Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
• Subjects who received other clinical trial drugs within 4 weeks of screening visit.
• 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
• Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 13620, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Inho Chae, M.D, Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 5, 2023
• Study Start: June 28, 2023
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)