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

NCT02899455 | Completed Phase 3

• 1 other identifier: HM-ALRO-301
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Hyperlipidemia

Keywords

Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

Experimental

EXPERIMENTAL

HGP0904 + HGP0608 + HGP0816, once daily

Drug: HGP0904; Drug: HGP0608; Drug: HGP0816

Active Comparator1

ACTIVE COMPARATOR

HGP0904 placebo + HGP0608 + HGP0816, once daily

Drug: HGP0608; Drug: HGP0816; Drug: HGP0904 Placebo

Active Comparator2

ACTIVE COMPARATOR

HGP0904 + HGP0608 + HGP0816 placebo, once daily

Drug: HGP0904; Drug: HGP0608; Drug: HGP0816 Placebo

Interventions

HGP0904 DRUG

Active Comparator2; Experimental

HGP0608 DRUG

Active Comparator1; Active Comparator2; Experimental

HGP0816 DRUG

Active Comparator1; Experimental

HGP0904 Placebo DRUG

Active Comparator1

HGP0816 Placebo DRUG

Active Comparator2

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

23 institutions including Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29150250 DERIVED

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)