Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Essential Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
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
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT06121518
Start Date
July 31 2023
End Date
March 26 2024
Last Update
April 5 2024
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, Seongdong-gu, South Korea, 04763