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Completed

NCT Number: NCT05931224

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

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

Completed

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

D064, D702, placebo of D660

Drug

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

Other names: D064, D702 are consisted of antihypertensive agent.

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

Other names: D660 is consisted of antihypertensive agent.

Primary outcomes

  1. Change from baseline in MSSBP

    Time frame: 8 weeks after drug administrations

    MSSBP(Mean Sitting Systolic Blood Pressure)

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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 D660 Monotherapy in Essential Hypertension Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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