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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899455
• Other study ID #: HM-ALRO-301
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2016
• Last updated: October 19, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2015
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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 B?: CHD risk factor=2 and 10 year risk <10%, 160mg/dL = LDL-C = 250mg/dL B?: 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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Drug:
• HGP0904

• HGP0608

• HGP0816

• HGP0904 Placebo

• HGP0816 Placebo

Locations

Country	Name	City	State
Korea, Republic of	23 institutions including Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in LDL-cholesterol at Week 8		baseline and 8 weeks
Primary	Change from baseline in sitDBP at Week 8		baseline and 8 weeks
Secondary	Percentage change from baseline in LDL cholesterol at Week 4		baseline and 4 weeks
Secondary	Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8		baseline, 4weeks and 8 weeks
Secondary	Change from baseline in sitDBP at Week 4		baseline and 4weeks
Secondary	Change from baseline in sitSBP at week 4, 8		baseline, 4weeks and 8 weeks
Secondary	Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8		baseline, 4weeks and 8 weeks
Secondary	Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8		baseline, 4weeks and 8 weeks
Secondary	Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8		baseline, 4weeks and 8 weeks