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CompletedNCT02899455Updated Oct 20, 2016

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

A Phase 3 interventional study of HGP0904 and HGP0608 in Hypertension and Hyperlipidemia, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-20.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hypertension
  • Hyperlipidemia

Keywords

  • Hypertension
  • Hyperlipidemia
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 146 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
146 participants (actual)

Study arms

  • 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

Interventions

  • DrugHGP0904
  • DrugHGP0608
  • DrugHGP0816
  • DrugHGP0904 Placebo
  • DrugHGP0816 Placebo
06

What researchers measure

Primary outcomes

  1. Percentage change from baseline in LDL-cholesterol at Week 8

    Time frame: baseline and 8 weeks

  2. Change from baseline in sitDBP at Week 8

    Time frame: baseline and 8 weeks

Secondary outcomes

  1. Percentage change from baseline in LDL cholesterol at Week 4

    Time frame: baseline and 4 weeks

  2. Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8

    Time frame: baseline, 4weeks and 8 weeks

  3. Change from baseline in sitDBP at Week 4

    Time frame: baseline and 4weeks

  4. Change from baseline in sitSBP at week 4, 8

    Time frame: baseline, 4weeks and 8 weeks

  5. Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8

    Time frame: baseline, 4weeks and 8 weeks

  6. Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8

    Time frame: baseline, 4weeks and 8 weeks

  7. 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

07

Study locations

1 site
  • 23 institutions including Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

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. PubMed 29150250 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02899455
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Sep 14, 2016
Start date
Jul 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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