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Clinical trial

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

ID
Name
A30_15HT2213
Description
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
Trial arms
Trial start
2023-06-28
Estimated PCD
2023-08-23
Trial end
2023-08-23
Status
Recruiting
Phase
Early phase I
Treatment
D064, D702, placebo of D660
Experimental Group Subjects assigned to this group are treated with D064, D702, placebo of D660
Arms:
Experimental Group
Other names:
D064, D702 are consisted of antihypertensive agent.
D660, placebo of D064, placebo of D702
Experimental Group Subjects assigned to this group are treated with D660, placebo of D064, placebo of D702
Arms:
Comparator Group
Other names:
D660 is consisted of antihypertensive agent.
Size
338
Primary endpoint
Change from baseline in MSSBP
8 weeks after drug administrations
Eligibility criteria
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: 1. Subjects with a history of secondary hypertension or suspected secondary hypertension 2. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs 3. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period 4. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening 5. Subjects who received other clinical trial drugs within 4 weeks of screening visit. 6. 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 7. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 338, 'type': 'ESTIMATED'}}
Updated at
2023-07-05

1 organization

2 products

1 indication

Product
D064
Indication
Hypertension
Organization
Chong Kun Dang Pharmaceutical
Product
D660