Hypertension
Conditions
Keywords
Losartan, Chlorthalidone
Brief summary
The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.
Detailed description
A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
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. Patients over 19 years of age 2. Patients who understands the process of clinical study and voluntarily signs a peer letter 3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions * Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg * Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg 4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg
Exclusion criteria
1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP 2. Orthostatic hypotension with symptoms within 3months of visit 1 3. Secondary hypertensive patient or suspected to be 4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus 5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL) 6. Severe heart disease or severe neurovascular disease 7. Severe or malignant retinopathy 8. Clinically significant hematological finding 9. Severe renal diseases (eGFR\<30mL/min/1.73m2) 10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) 11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L) 12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L) 13. Hypercalcemia 14. History of malignancy tumor 15. History of autoimmune disease 16. History of alcohol or drug abuse 17. Positive to pregnancy test, nursing mother, intention on pregnancy 18. Considered by investigator as not appropriate to participate in the clinical study with othe reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure(mmHg) | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure(mmHg) | Week 4 |
| Change from baseline in mean sitting diastolic blood pressure(mmHg) | Week 4,8 |
| Change from baseline in mean pulse blood pressure(mmHg) | Week 4,8 |
| Target blood pressure reach rate(%) | Week 4,8 |
| Blood pressure responder rate(%) | Week 4,8 |
Countries
South Korea
Outcome results
None listed