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

NCT ID: NCT02770261

Last Updated: 2016-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-10-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension Cholesterolemia

Keywords

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DP-R208

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CR group

DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla

Group Type EXPERIMENTAL

DP-R208

Intervention Type DRUG

DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo

Candesartan32mg Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Rosuvastatin 20mg Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

CP group

DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla

Group Type ACTIVE_COMPARATOR

Candesartan32mg

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

DP-R208 Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Rosuvastatin 20mg Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

PR group

DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

DP-R208 Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Candesartan32mg Placebo

Intervention Type DRUG

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Interventions

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DP-R208

DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo

Intervention Type DRUG

Candesartan32mg

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

Intervention Type DRUG

Rosuvastatin 20mg

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Intervention Type DRUG

DP-R208 Placebo

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Intervention Type DRUG

Candesartan32mg Placebo

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Intervention Type DRUG

Rosuvastatin 20mg Placebo

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

Intervention Type DRUG

Other Intervention Names

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Candesartan Rosuvastatin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changkyu Park

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31307833 (View on PubMed)

Other Identifiers

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DP-CTR208-III-03

Identifier Type: -

Identifier Source: org_study_id