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

Alvogen

Status and phase: Completed; Phase 3

Conditions: Cholesterolemia; Hypertension

Treatments: Drug: Candesartan32mg Placebo; Drug: DP-R208 Placebo; Drug: Rosuvastatin 20mg Placebo; Drug: Candesartan32mg; Drug: Rosuvastatin 20mg; Drug: DP-R208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02770261

DP-CTR208-III-03

Details and patient eligibility

About

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

Enrollment: 219 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 3 patient groups

CR group

Experimental group

Description:

DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla

Treatment:

Drug: DP-R208

Drug: Rosuvastatin 20mg Placebo

Drug: Candesartan32mg Placebo

CP group

Active Comparator group

Description:

DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla

Treatment:

Drug: Candesartan32mg

Drug: Rosuvastatin 20mg Placebo

Drug: DP-R208 Placebo

PR group

Active Comparator group

Description:

DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin 20mg

Drug: DP-R208 Placebo

Drug: Candesartan32mg Placebo