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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05526703
Enrollment
108
Registered
2022-09-02
Start date
2022-09-28
Completion date
2023-10-31
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DRUGD064, D701, placebo of D012

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

DRUGD012, placebo of D064, placebo of D701

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

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in MSSBP8 weeks after drug administrationsCompare experimental group with comparator group

Countries

South Korea

Contacts

Primary ContactYeonhwa Park, Project Leader
yeonhwa@ckdpharm.com82-2-6373-0636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026