Clinical trial NCT02899455: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Keywords: Hypertension
Hyperlipidemia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 146
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change from baseline in LDL-cholesterol at Week 8
timeFrame: baseline and 8 weeks
measure: Change from baseline in sitDBP at Week 8
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Percentage change from baseline in LDL cholesterol at Week 4
timeFrame: baseline and 4 weeks
measure: Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8
timeFrame: baseline, 4weeks and 8 weeks
measure: Change from baseline in sitDBP at Week 4
timeFrame: baseline and 4weeks
measure: Change from baseline in sitSBP at week 4, 8
timeFrame: baseline, 4weeks and 8 weeks
measure: Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8
timeFrame: baseline, 4weeks and 8 weeks
measure: Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8
timeFrame: baseline, 4weeks and 8 weeks
measure: Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8
timeFrame: baseline, 4weeks and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 23 institutions including Samsung Medical Center
Study officials:
References:
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.