Back to resultsClinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
Primary Purpose
Hypertension, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HGP0904
HGP0608
HGP0816
HGP0904 Placebo
HGP0816 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- 19 ≤ age ≤ 75
- at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG < 400mg/dL
- 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:
- At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
- Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
- CPK normal range ≥ 3times
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
- Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
- Active gout or hyperuricemia(at Visit 1, uric acid > 9mg/dL)
- IDDM or uncontrolled diabetes mellitus (HbA1c>9%)
- ventricular arrhythmia
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
Sites / Locations
- 23 institutions including Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Experimental
Active Comparator1
Active Comparator2
Arm Description
HGP0904 + HGP0608 + HGP0816, once daily
HGP0904 placebo + HGP0608 + HGP0816, once daily
HGP0904 + HGP0608 + HGP0816 placebo, once daily
Outcomes
Primary Outcome Measures
Percentage change from baseline in LDL-cholesterol at Week 8
Change from baseline in sitDBP at Week 8
Secondary Outcome Measures
Percentage change from baseline in LDL cholesterol at Week 4
Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8
Change from baseline in sitDBP at Week 4
Change from baseline in sitSBP at week 4, 8
Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8
Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8
Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8
Full Information
NCT ID
NCT02899455
First Posted
September 9, 2016
Last Updated
October 19, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02899455
Brief Title
Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
Official Title
Efficacy and Safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase 3 Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia
Keywords
Hypertension, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
HGP0904 + HGP0608 + HGP0816, once daily
Arm Title
Active Comparator1
Arm Type
Active Comparator
Arm Description
HGP0904 placebo + HGP0608 + HGP0816, once daily
Arm Title
Active Comparator2
Arm Type
Active Comparator
Arm Description
HGP0904 + HGP0608 + HGP0816 placebo, once daily
Intervention Type
Drug
Intervention Name(s)
HGP0904
Intervention Type
Drug
Intervention Name(s)
HGP0608
Intervention Type
Drug
Intervention Name(s)
HGP0816
Intervention Type
Drug
Intervention Name(s)
HGP0904 Placebo
Intervention Type
Drug
Intervention Name(s)
HGP0816 Placebo
Primary Outcome Measure Information:
Title
Percentage change from baseline in LDL-cholesterol at Week 8
Time Frame
baseline and 8 weeks
Title
Change from baseline in sitDBP at Week 8
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Percentage change from baseline in LDL cholesterol at Week 4
Time Frame
baseline and 4 weeks
Title
Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8
Time Frame
baseline, 4weeks and 8 weeks
Title
Change from baseline in sitDBP at Week 4
Time Frame
baseline and 4weeks
Title
Change from baseline in sitSBP at week 4, 8
Time Frame
baseline, 4weeks and 8 weeks
Title
Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8
Time Frame
baseline, 4weeks and 8 weeks
Title
Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8
Time Frame
baseline, 4weeks and 8 weeks
Title
Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8
Time Frame
baseline, 4weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 ≤ age ≤ 75
at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG < 400mg/dL
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:
At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg
Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
CPK normal range ≥ 3times
Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times)
Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times)
Active gout or hyperuricemia(at Visit 1, uric acid > 9mg/dL)
IDDM or uncontrolled diabetes mellitus (HbA1c>9%)
ventricular arrhythmia
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
Facility Information:
Facility Name
23 institutions including Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29150250
Citation
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.
Results Reference
derived
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Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia
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