Hyperlipidemia, Hypertension
Conditions
Keywords
Hypertension, Hyperlipidemia
Brief summary
A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
Detailed description
This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia
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 75 Years
Healthy volunteers
No
Inclusion criteria
1. 19 ≤ age ≤ 75 2. at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG \< 400mg/dL 3. at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP \< 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk \<10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents\* or 10 year risk\>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG \< 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form
Exclusion criteria
1. At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg 2. Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy 3. Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin 4. CPK normal range ≥ 3times 5. Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times) 6. Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times) 7. Active gout or hyperuricemia(at Visit 1, uric acid \> 9mg/dL) 8. IDDM or uncontrolled diabetes mellitus (HbA1c\>9%) 9. ventricular arrhythmia 10. medical history * severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension * encephalopathy, transient cerebral ischemic attack(TIA) * severe heart disease(heart failure of NYHA class III-IV), valvular disease of heart or myocardial infarction and unstable angina * angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in LDL-cholesterol at Week 8 | baseline and 8 weeks |
| Change from baseline in sitDBP at Week 8 | baseline and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sitDBP at Week 4 | baseline and 4weeks |
| Change from baseline in sitSBP at week 4, 8 | baseline, 4weeks and 8 weeks |
| Percentage change from baseline in LDL cholesterol at Week 4 | baseline and 4 weeks |
| Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8 | baseline, 4weeks and 8 weeks |
| Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8 | baseline, 4weeks and 8 weeks |
| Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8 | baseline, 4weeks and 8 weeks |
| Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8 | baseline, 4weeks and 8 weeks |
Countries
South Korea
Outcome results
None listed