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Completed

NCT Number: NCT06121518

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Seoul Hospital

Seoul, Seongdong-gu, 04763, South Korea

About this study

This study is 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

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 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.

Exclusion criteria

  • Subjects with a history of secondary hypertension or suspected secondary hypertension
  • Subjects with symptomatic orthostatic hypotension
  • Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c > 9.0%)
  • 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 disability to investigational product ADME at the time of screening
  • Subjects with abnormalities in laboratory test results 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 with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
  • 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
  • Subjects who are unable to participate in this clinical trial at the discretion of the investigator

Treatment and study plan

D064 and D702, QD

Drug

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

Other names: D064 and D702 Combination Therapy

D064 and Placebo of D702, QD

Drug

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

Other names: D064 Monotherapy

Placebo of D064 and D702, QD

Drug

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

Other names: D702 Monotherapy

Primary outcomes

  1. Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))

    Time frame: 8 weeks

    Compare experimental group with comparator group

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 D064 or D702 Monotherapy in Essential Hypertension Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Apr 5, 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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