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

NCT02770261 — Phase 3, Completed, 219 participants, Alvogen Korea

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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.

Registry	NCT02770261
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	219 (Actual)
Sponsor	Alvogen Korea (Industry)
Conditions	Hypertension, Cholesterolemia
Interventions	DP-R208, Candesartan32mg, Rosuvastatin 20mg, DP-R208 Placebo, Candesartan32mg Placebo, Rosuvastatin 20mg Placebo (Drug)
Dates	start 2015-12-01, primary completion 2016-08-01, completion 2016-10-01, first posted 2016-05-12, last updated 2016-12-26
Locations	1 site in South Korea

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
CR group	Experimental	Drug: DP-R208; Drug: Candesartan32mg Placebo; Drug: Rosuvastatin 20mg Placebo	DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
CP group	Active comparator	Drug: Candesartan32mg; Drug: DP-R208 Placebo; Drug: Rosuvastatin 20mg Placebo	DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
PR group	Active comparator	Drug: Rosuvastatin 20mg; Drug: DP-R208 Placebo; Drug: Candesartan32mg Placebo	DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg

DP-R208 (Drug): DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo
Candesartan32mg (Drug), also known as Candesartan: DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Rosuvastatin 20mg (Drug), also known as Rosuvastatin: DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
DP-R208 Placebo (Drug): DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Candesartan32mg Placebo (Drug): DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Rosuvastatin 20mg Placebo (Drug): DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

+Outcome measures

Primary outcomes

Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol [8weeks]

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Korea University Guro Hospital	Seoul	South Korea

+Publications

Results publication: 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 31307833

+Investigators

Changkyu Park, Principal investigator, Korea University Guro Hospital