Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

Hyperlipidemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451098
• Other study ID #: 152PDL14025
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2015
• Last updated: January 26, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

Description:

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult, at least 19 years of age.

• Hyperlipidemia patient of LDL-C=250 mg/dl and TG =400 mg/dl

• Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]

• Drug compliance during Run-in period =70%

• Patients must willing to the study and signed an informed consent

Exclusion Criteria:

• Patients with myopathy included rhabdomyolysis or CPK level=2xULN

• Patients with acute arterial disease

• Patients with renal dysfunction or Serum creatinine level =2x ULN

• Patients with liver dysfunction or ALT, AST level > 2xULN

• Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)

• Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP=180mmHg or DBP=110mmHg, hypothyroidism as TSH=1.5xULN)

• Patients who have a history or presence of active malignancy within 5 years

• Patients with difficulty of stop taking lipid-lowering agents during run-in period.

• Patients who have taken another investigational drug within 4 weeks prior to screening visit.

Study Design

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
• Atorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
• Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
• Atorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
• Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
• Atorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of korea seoul st. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.		up to week 20	Yes
Primary	Change form baseline in LDL-C		up to week 8	No
Secondary	Change form baseline in LDL-C		up to week 20	No
Secondary	Change form baseline in Total cholesterol		up to week 20	No
Secondary	Change form baseline in Triglyceride		up to week 20	No
Secondary	Change form baseline in HDL-C		up to week 20	No
Secondary	Change form baseline in Non-HDL-C		up to week 20	No
Secondary	Change form baseline in LDL-C/HDL-C ratio		up to week 20	No
Secondary	Change form baseline in TC/HDL-C ratio		up to week 20	No
Secondary	Change form baseline in Non-HDL-C/HDL-C ratio		up to week 20	No
Secondary	Change form baseline in Apo-B ratio		up to week 20	No
Secondary	Change form baseline in Apo-B		up to week 20	No
Secondary	Change form baseline in Apo-A1		up to week 20	No
Secondary	Change form baseline in Apo-B/Apo-A1 ratio		up to week 20	No