Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy

Phase 3

Completed

• Conditions: Hypertension; Cholesterolemia
• Interventions: Drug: Rosuvastatin 20mg; Drug: DP-R208; Drug: Candesartan32mg; Drug: DP-R208 Placebo; Drug: Rosuvastatin 20mg Placebo; Drug: Candesartan32mg Placebo

• Registration Number: NCT02770261
• Lead Sponsor: Alvogen Korea

Brief Summary

The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• Both man and woman who is over 19years old.
• Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL

Exclusion Criteria

• Therapeutic lifestylechange is not enought during the study period
• SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PR group	Rosuvastatin 20mg	DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
CR group	DP-R208	DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
CP group	Rosuvastatin 20mg Placebo	DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
PR group	DP-R208 Placebo	DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
CR group	Rosuvastatin 20mg Placebo	DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
PR group	Candesartan32mg Placebo	DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
CR group	Candesartan32mg Placebo	DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
CP group	Candesartan32mg	DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
CP group	DP-R208 Placebo	DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla

Primary Outcome Measures

Name	Time	Method
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol	8weeks

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of