Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy
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.
1 other identifier
interventional
219
1 country
1
Brief Summary
The purpose of this study is to determine superiority of DP-R208 compare 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
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Dec 2015
Shorter than P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 26, 2016
December 1, 2016
8 months
May 11, 2016
December 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol
8weeks
Study Arms (3)
CR group
EXPERIMENTALDP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
CP group
ACTIVE COMPARATORDP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
PR group
ACTIVE COMPARATORDP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
Interventions
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
Related Publications (1)
Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12.
PMID: 31307833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changkyu Park
Korea University Guro Hospital
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
May 11, 2016
First Posted
May 12, 2016
Study Start
December 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
December 26, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share