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Completed

NCT Number: NCT02770261

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Cholesterolemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DP-R208

Drug

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

Candesartan32mg

Drug

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

Other names: Candesartan

Rosuvastatin 20mg

Drug

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

Other names: Rosuvastatin

DP-R208 Placebo

Drug

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

Candesartan32mg Placebo

Drug

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

Rosuvastatin 20mg Placebo

Drug

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

Primary outcomes

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

    Time frame: 8weeks

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Dec 26, 2016

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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