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

December 23, 2016 updated by: Alvogen Korea

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CR group
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
Drug: DP-R208
DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo
Drug: Candesartan32mg Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Drug: Rosuvastatin 20mg Placebo
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Active Comparator: CP group
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
Drug: Rosuvastatin 20mg Placebo
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Drug: Candesartan32mg
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Other Names:
  • Candesartan
Drug: DP-R208 Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Active Comparator: PR group
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
Drug: Candesartan32mg Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Drug: DP-R208 Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Drug: Rosuvastatin 20mg
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Other Names:
  • Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
Time Frame: 8weeks
8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Investigators

  • Principal Investigator: Changkyu Park, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

December 26, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR208-III-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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