Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

June 1, 2017 updated by: Alvogen Korea

A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension

The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

19 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 19 years old
  • Hypertension patient with hypercholesterolemia

Exclusion Criteria:

  • sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
  • A history of cardiovascular disease
  • rhabdomyolysis, myopathy
  • Hypertension or hypercholesterolemia due to secondary causes
  • Uncontrolled diabetes
  • Evidence of hepatic or renal disease

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: DP-R212 group
DP-R212 + C1-R212 placebo + C2-R212 placebo
Drug: DP-R212
DP-R212 + C1-R212 placebo + C2-R212 placebo
Active Comparator: C1-R212 group
DP-R212 placebo + C1-R212 + C2-R212 placebo
Drug: C1-R212
DP-R212 placebo + C1-R212 + C2-R212 placebo
Active Comparator: C2-R212 group
DP-R212 placebo + C1-R212 placebo + C2-R212
Drug: C2-R212
DP-R212 placebo + C1-R212 placebo + C2-R212

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change of LDL-Cholesterol
Time Frame: 0, 8 weeks
0, 8 weeks
Change of mean seated Systolic Blood Pressure
Time Frame: 0, 8 weeks
0, 8 weeks

Collaborators and Investigators

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

Sponsor

Alvogen Korea

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 (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR212-III-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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