- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955368
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Withdrawn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
|
DP-R212 + C1-R212 placebo + C2-R212 placebo
|
Active Comparator: C1-R212 group
DP-R212 placebo + C1-R212 + C2-R212 placebo
|
DP-R212 placebo + C1-R212 + C2-R212 placebo
|
Active Comparator: C2-R212 group
DP-R212 placebo + C1-R212 placebo + 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
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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