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OpenTrials
Completed

NCT Number: NCT02445352

Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seodaemun-gu, Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged over 19 years
  • Signed informed consent form
  • At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Exclusion criteria

  • Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
  • Liver transaminases > 2 x upper limit of normal

Treatment and study plan

Rosuvastatin 5mg

Drug

DP-R207 5/10mg

Drug

Other names: Rosuvastatin 5mg, Ezetimibe 10mg

Rosuvastatin 10mg

Drug

DP-R207 10/10mg

Drug

Other names: Rosuvastatin 10mg, Ezetimibe 10mg

Rosuvastatin 20mg

Drug

DP-R207 20/10mg

Drug

Other names: Rosuvastatin 20mg, Ezetimibe 10mg

Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)

Drug

Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)

Drug

Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)

Drug

Primary outcomes

  1. Percent change from baseline to 8 weeks in LDL-Cholesterol

    Time frame: baseline and 8 weeks

Secondary outcomes

  1. Percent change from baseline to 4 weeks in LDL-Cholesterol

    Time frame: baseline and 4 weeks

  2. Percent change from baseline to 4 weeks in lipid related blood test results

    Time frame: baseline and 4 weeks

  3. Percent change from baseline to 8 weeks in lipid related blood test results

    Time frame: baseline and 8 weeks

  4. Percentage of patients reaching treatment goals according to NCEP ATP III Guideline

    Time frame: week 4 and week 8

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Acronym: ROSE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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