Dyslipidemias, Hypertension
Conditions
Brief summary
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia
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
* Age ≥ 19 * Patients who understood the contents and purpose of this trial and signed informed consent form * Patients with essential hypertension and dyslipidemia
Exclusion criteria
* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP * Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg * Concomitant administration of cyclosporine * Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy * Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers * Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin * CPK normal range \> 2 times * Secondary hypertension and suspected secondary hypertension * Orthostatic hypotension with symptoms * Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times) * Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) * Active gout or hyperuricemia(uric acid ≥ 9mg/dL) * IDDM or uncontrolled type 2 diabetes mellitus (HbA1c \> 9%) * Ventricular arrhythmia * Medical history * Severe heart disease(heart failure of NYHA class III-IV) * Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA) * Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve * Ischemic heart disease(myocardial infarction, angina) within 6months * Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in LDL-C (%) | baseline, 8 weeks | Experimental, Active Control 1 |
| Change from baseline in sitting systolic blood pressure | baseline, 8 weeks | Experimental, Active Control 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in TC, HDL-C, TG (%) | baseline, 4 weeks, 8 weeks | — |
| Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks | — |
| Proportion of subject achieving LDL-C control | baseline, 4 weeks, 8 weeks | — |
| Change from baseline in LDL-C (%) | baseline, 8 weeks | Experimental, Active Control 2 |
| Proportion of responder for blood pressure | baseline, 4 weeks, 8 weeks | — |
| Proportion of subject achieving both LDL-C and blood pressure control | baseline, 4 weeks, 8 weeks | — |
| Proportion of subjects achieving blood pressure control | baseline, 4 weeks, 8 weeks | — |
| Change from baseline in sitting systolic blood pressure | baseline, 8 weeks | Experimental, Active Control 1 |
Countries
South Korea
Outcome results
None listed