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

Alvogen Korea219 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

219

Conditions

Hypertension Cholesterolemia

Interventions

DP-R208DRUG

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

Candesartan32mgDRUG

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

Rosuvastatin 20mgDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol

Time frame: 8weeks

Data from ClinicalTrials.gov

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