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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02899455

HM-ALRO-301

Details and patient eligibility

About

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

Full 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

Enrollment: 146 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 3 patient groups

Experimental

Experimental group

Description:

HGP0904 + HGP0608 + HGP0816, once daily

Treatment:

Drug: HGP0816

Drug: HGP0904

Drug: HGP0608

Active Comparator1

Active Comparator group

Description:

HGP0904 placebo + HGP0608 + HGP0816, once daily

Treatment:

Drug: HGP0816

Drug: HGP0904 Placebo

Drug: HGP0608

Active Comparator2

Active Comparator group

Description:

HGP0904 + HGP0608 + HGP0816 placebo, once daily

Treatment:

Drug: HGP0816 Placebo

Drug: HGP0904

Drug: HGP0608