Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

Hyperlipidemias Clinical Trial

Official title:

An Efficacy and Safety Study of HCP1105 Capsule in Combined Hyperlipidemic Patients With High Risk for Coronary Heart Disease (CHD): A Randomized,Double-blind, Multicenter, Phase 3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02551172
• Other study ID #: HM-ROMA-301
• Status: Recruiting
• Phase: Phase 3
• First received: September 11, 2015
• Last updated: September 15, 2015
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Chang-Hee Jung
• Phone: 02-3010-3246
• Email: chjung0204[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.

Description:

An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• age 19=

• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

• History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3

• Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• HCP1105
Rosuvastatin + Omega-3-acids ethyl esters
• HGP0816
Rosuvastatin
• Placebo of HCP1105
Soybean Oil
• Placebo of HGP0816
Exclusion of Rosuvastatin in HGP0816

Locations

Country	Name	City	State
Korea, Republic of	Euljii General Hospital	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	Mean rate of change of non-HDL-C (%) from baseline		12 weeks	No
Secondary	Mean rate of change of HDL-C (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of LDL-C (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of Triglyceride (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of Total cholesterol (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of Total apo A1 (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of Total apo B (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of Lipoprotein(a) (%) from baseline		4, 8, 12 weeks	No
Secondary	Mean rate of change of hs-CRP (%) from baseline		4, 8, 12 weeks	No
Secondary	Rate of the subjects who meet the target level of treatment	target level (Non-HDL-C<130mg/dL)	4, 8, 12 weeks	No