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NCT02770261 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02770261
Other study ID # DP-CTR208-III-03
Secondary ID
Status Completed
Phase Phase 3
First received May 11, 2016
Last updated December 23, 2016
Start date December 2015
Est. completion date October 2016

Study information
Verified date December 2016
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DP-R208
DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo
• Candesartan32mg
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
• Rosuvastatin 20mg
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
• DP-R208 Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
• Candesartan32mg Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
• Rosuvastatin 20mg Placebo
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol 8weeks No
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