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

Phase 3

Withdrawn

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Drug: C1-R212; Drug: C2-R212; Drug: DP-R212

• Registration Number: NCT02955368
• Lead Sponsor: Alvogen Korea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2017-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-05
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C1-R212 group	C1-R212	DP-R212 placebo + C1-R212 + C2-R212 placebo
C2-R212 group	C2-R212	DP-R212 placebo + C1-R212 placebo + C2-R212
DP-R212 group	DP-R212	DP-R212 + C1-R212 placebo + C2-R212 placebo

Primary Outcome Measures

Name	Time	Method
Change of mean seated Systolic Blood Pressure	0, 8 weeks
Percent change of LDL-Cholesterol	0, 8 weeks