Study Stopped
Canceled
Clinical Trial to Evaluate the Efficacy and Safety of DP-R212
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
Shorter than P25 for phase_3 hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 5, 2017
June 1, 2017
5 months
November 1, 2016
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change of LDL-Cholesterol
0, 8 weeks
Change of mean seated Systolic Blood Pressure
0, 8 weeks
Study Arms (3)
DP-R212 group
EXPERIMENTALDP-R212 + C1-R212 placebo + C2-R212 placebo
C1-R212 group
ACTIVE COMPARATORDP-R212 placebo + C1-R212 + C2-R212 placebo
C2-R212 group
ACTIVE COMPARATORDP-R212 placebo + C1-R212 placebo + C2-R212
Interventions
Eligibility Criteria
You may qualify if:
- Both man and woman who is over 19 years old
- Hypertension patient with hypercholesterolemia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
November 4, 2016
Study Start
February 1, 2017
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
June 5, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share