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

NCT05526703 | Unknown Phase 3

• 1 other identifier: A30_14HT2209
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MSSBP

  Compare experimental group with comparator group

  8 weeks after drug administrations

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: D064, D701, placebo of D012

Comparator Group

ACTIVE COMPARATOR

Drug: D012, placebo of D064, placebo of D701

Interventions

D064, D701, placebo of D012 DRUG

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

Also known as: D064, D701 are consisted of antihypertensive agent.

Experimental Group

D012, placebo of D064, placebo of D701 DRUG

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

Also known as: D012 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 who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
• 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)

Samsung Medical Center

Seoul, ASI|KR|KS013|SEOUL, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yeonhwa Park, Project Leader

CONTACT

82-2-6373-0636; yeonhwa@ckdpharm.com

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: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 28, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)