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NCT02955368 Clinical Trial

Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02955368
Other study ID # DP-CTR212-III-03
Secondary ID
Status Withdrawn
Phase Phase 3
First received November 1, 2016
Last updated June 1, 2017
Start date February 2017
Est. completion date August 2017

Study information
Verified date June 2017
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Both man and woman who is over 19 years old

- Hypertension patient with hypercholesterolemia

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DP-R212
DP-R212 + C1-R212 placebo + C2-R212 placebo
• C1-R212
DP-R212 placebo + C1-R212 + C2-R212 placebo
• C2-R212
DP-R212 placebo + C1-R212 placebo + C2-R212

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change of LDL-Cholesterol 0, 8 weeks
Primary Change of mean seated Systolic Blood Pressure 0, 8 weeks
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