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

Alvogen

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: Rosuvastatin 10mg; Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg); Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg); Drug: DP-R207 20/10mg; Drug: DP-R207 5/10mg; Drug: Rosuvastatin 20mg; Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg); Drug: DP-R207 10/10mg; Drug: Rosuvastatin 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02445352

DP-CTR207-III-02

Details and patient eligibility

About

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

Enrollment: 379 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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379 participants in 6 patient groups

Rosuvastatin 5mg & Placebo & Placebo

Active Comparator group

Description:

Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks

Treatment:

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

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

Drug: Rosuvastatin 5mg

DP-R207 5/10mg & Placebo & Placebo

Experimental group

Description:

Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks

Treatment:

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

Drug: DP-R207 5/10mg

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

Rosuvastatin 10mg & Placebo & Placebo

Active Comparator group

Description:

Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks

Treatment:

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

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

Drug: Rosuvastatin 10mg

DP-R207 10/10mg & Placebo & Placebo

Experimental group

Description:

Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks

Treatment:

Drug: DP-R207 10/10mg

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

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

Rosuvastatin 20mg & Placebo & Placebo

Active Comparator group

Description:

Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks

Treatment:

Drug: Rosuvastatin 20mg

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

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

DP-R207 20/10mg & Placebo & Placebo

Experimental group

Description:

Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks

Treatment:

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

Drug: DP-R207 20/10mg

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