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

Efficacy and Safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase 3 Study

A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Drug: HGP0904; Drug: HGP0608; Drug: HGP0816; Drug: HGP0904 Placebo; Drug: HGP0816 Placebo

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 Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 23 institutions including Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; HGP0904 + HGP0608 + HGP0816, once daily	Drug: HGP0904; Drug: HGP0608; Drug: HGP0816
Active Comparator: Active Comparator1; HGP0904 placebo + HGP0608 + HGP0816, once daily	Drug: HGP0608; Drug: HGP0816; Drug: HGP0904 Placebo
Active Comparator: Active Comparator2; HGP0904 + HGP0608 + HGP0816 placebo, once daily	Drug: HGP0904; Drug: HGP0608; Drug: HGP0816 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Publications and helpful links

General Publications

• Lee HY, Kim SY, Choi KJ, Yoo BS, Cha DH, Jung HO, Ryu DR, Choi JH, Lee KJ, Park TH, Oh JH, Kim SM, Choi JY, Kim KH, Shim J, Kim WS, Choi SW, Park DG, Song PS, Hong TJ, Rhee MY, Rha SW, Park SW. A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia. Clin Ther. 2017 Dec;39(12):2366-2379. doi: 10.1016/j.clinthera.2017.10.013. Epub 2017 Nov 14.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension; Hyperlipidemia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: HM-ALRO-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO