Status:
COMPLETED
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 Dyslipid...
Eligibility Criteria
Inclusion
- Age ≥ 19
- Patients who understood the contents and purpose of this trial and signed informed consent form
- Patients with essential hypertension and dyslipidemia
Exclusion
- 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
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04074551
Start Date
July 16 2019
End Date
March 17 2020
Last Update
November 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080