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NCT06121518CompletedPhase 3

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

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Source: ClinicalTrials.gov · Last updated 5 Apr 2024

Brief summary (registry, in English)

The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
235 (actual)
First submitted
24 Oct 2023
Start date
31 Jul 2023
Primary completion date
22 Mar 2024
Lead sponsor
Chong Kun Dang Pharmaceutical
NCT number
NCT06121518

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 235
  • From 31 Jul 2023 to the primary completion date, 22 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects with a history of disability to investigational product ADME at the time of screening
  • Subjects with hypersensitivity or history of investigational product 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 who received other investigational product 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 investigational product

Other illness

  • Subjects with a history of secondary hypertension or suspected secondary hypertension
  • Subjects with Severe heart failure(NYHA Class 3,4) etc.,
  • Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
  • Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening

Lab values

  • Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \> 9.0%)
  • Subjects with abnormalities in laboratory test results at the time of screening

Other

  • Subjects with symptomatic orthostatic hypotension
  • Subjects who are unable to participate in this clinical trial at the discretion of the investigator

Who the study is looking for

  • Subjects who are 19 years old or older.
  • Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:
    • Didn't take antihypertensive drug
    • 140 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
    • Taking antihypertensive drug
    • 130 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
  • Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hanyang University Seoul Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.