Essential Hypertension
Conditions
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 in Essential Hypertension Patients
Interventions
DRUGD064 and D702, QD
Experimental Group Subjects assigned to this group are treated with D064, D702
DRUGD064 and Placebo of D702, QD
Comparator Group Subjects assigned to this group are treated with D064, placebo of D702
DRUGPlacebo of D064 and D702, QD
Comparator Group Subjects assigned to this group are treated with D702, placebo of D064
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who are 19 years old or older. 2. 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 3. 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 symptomatic orthostatic hypotension 3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \> 9.0%) 4. Subjects with Severe heart failure(NYHA Class 3,4) etc., 5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening 6. Subjects with a history of disability to investigational product ADME at the time of screening 7. Subjects with abnormalities in laboratory test results at the time of screening 8. Subjects with hypersensitivity or history of investigational product and similar drugs 9. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period 10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening 11. Subjects who received other investigational product within 4 weeks of screening visit 12. 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 13. Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure)) | 8 weeks | Compare experimental group with comparator group |
Countries
South Korea
Outcome results
None listed