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The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients

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ClinicalTrials.gov Identifier: NCT02251847
Recruitment Status : Unknown
Verified September 2014 by IlDong Pharmaceutical Co Ltd.
Recruitment status was:  Recruiting
First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin/Ezetimibe Phase 3

Detailed Description:
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015


Arm Intervention/treatment
Active Comparator: R5
Rosuvastatin 5mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Active Comparator: R10
Rosuvastatin 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Active Comparator: R20
Rosuvastatin 20mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Experimental: R5/E10
Rosuvastatin 5mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Experimental: R10/E10
Rosuvastatin 10mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Experimental: R20/E10
Rosuvastatin 20mg/ezetimibe 10mg
Drug: Rosuvastatin/Ezetimibe
Rosuvastatin 5mg




Primary Outcome Measures :
  1. Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: baseline and 8 week ]

Secondary Outcome Measures :
  1. Percent change from baseline to 4 week in LDL-Cholesterol [ Time Frame: baseline and 4 week ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypercholesterolemic patient

Exclusion Criteria:

  • Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251847


Contacts
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Contact: Min-Hee Kwon 02-526-3379 minhee@ildong.com

Locations
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Korea, Republic of
Gil Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Tae Hoon Ahn         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
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Principal Investigator: Tae Hoon Ahn Gachon University Gil Medical Center

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02251847     History of Changes
Other Study ID Numbers: ID-ROEZ-301
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by IlDong Pharmaceutical Co Ltd:
cholesterol

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors