Last updated: April 3, 2024
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Completed
Phase
3
Condition
Diabetes And Hypertension
High Blood Pressure (Hypertension)
Circulation Disorders
Treatment
D064 and D702, QD
Placebo of D064 and D702, QD
D064 and Placebo of D702, QD
Clinical Study ID
NCT06121518
A30_17HT2222
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects who are 19 years old or older.
- Subjects who are mean blood pressure measured in the arm selected as the reference armmeets 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 signedICF.
Exclusion
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 ofscreening
- 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 inthis plan during the clinical trial participation period
- Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeksas 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 appropriatecontraception during the clinical trial period and for two weeks after the end ofadministration of the last investigational product
- Subjects who are unable to participate in this clinical trial at the discretion of theinvestigator
Study Design
Total Participants: 235
Treatment Group(s): 3
Primary Treatment: D064 and D702, QD
Phase: 3
Study Start date:
July 31, 2023
Estimated Completion Date:
March 26, 2024
Study Description
Connect with a study center
Hanyang University Seoul Hospital
Seoul, Seongdong-gu 04763
Korea, Republic ofSite Not Available

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