NCT04074551
Completed
Phase 3
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
Hanmi Pharmaceutical Company Limited1 site in 1 country145 target enrollmentJuly 16, 2019
Overview
- Phase
- Phase 3
- Intervention
- HCP1701
- Conditions
- Hypertension
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Change from baseline in LDL-C (%)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Arms & Interventions
Experimental
HCP1701
Intervention: HCP1701
Active Comparator 1
HGP0904, HGP0608
Intervention: Losartan
Active Comparator 1
HGP0904, HGP0608
Intervention: Amlodipine
Active Comparator 2
HGP0608, HCP1306
Intervention: Losartan
Active Comparator 2
HGP0608, HCP1306
Intervention: Rosuvastatin and Ezetimibe
Outcomes
Primary Outcomes
Change from baseline in LDL-C (%)
Time Frame: baseline, 8 weeks
Experimental, Active Control 1
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 8 weeks
Experimental, Active Control 2
Secondary Outcomes
- 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)
- Proportion of subjects achieving blood pressure control(baseline, 4 weeks, 8 weeks)
- Proportion of responder for blood pressure(baseline, 4 weeks, 8 weeks)
- Change from baseline in TC, HDL-C, TG (%)(baseline, 4 weeks, 8 weeks)
- Proportion of subject achieving both LDL-C and blood pressure control(baseline, 4 weeks, 8 weeks)
- Change from baseline in sitting systolic blood pressure(baseline, 4 weeks)
- Change from baseline in LDL-C (%)(baseline, 4 weeks)
Study Sites (1)
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