Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia

Phase 3

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: HGP0904; Drug: HGP0608; Drug: HGP0816 Placebo; Drug: HGP0816; Drug: HGP0904 Placebo

• Registration Number: NCT02899455
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2014-07
• Status Verified: 2015-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	HGP0608	HGP0904 + HGP0608 + HGP0816, once daily
Active Comparator2	HGP0816 Placebo	HGP0904 + HGP0608 + HGP0816 placebo, once daily
Experimental	HGP0816	HGP0904 + HGP0608 + HGP0816, once daily
Active Comparator1	HGP0904 Placebo	HGP0904 placebo + HGP0608 + HGP0816, once daily
Active Comparator1	HGP0608	HGP0904 placebo + HGP0608 + HGP0816, once daily
Active Comparator1	HGP0816	HGP0904 placebo + HGP0608 + HGP0816, once daily
Active Comparator2	HGP0608	HGP0904 + HGP0608 + HGP0816 placebo, once daily
Experimental	HGP0904	HGP0904 + HGP0608 + HGP0816, once daily
Active Comparator2	HGP0904	HGP0904 + HGP0608 + HGP0816 placebo, once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage change from baseline in LDL cholesterol at Week 4	baseline and 4 weeks
Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8	baseline, 4weeks and 8 weeks
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
Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8	baseline, 4weeks and 8 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

Trial Locations

Locations (1)

23 institutions including Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of