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

NCT ID: NCT02955368

Last Updated: 2017-06-05

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Hypertension Hypercholesterolemia

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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DP-R212 group

DP-R212 + C1-R212 placebo + C2-R212 placebo

Group Type EXPERIMENTAL

DP-R212

Intervention Type DRUG

DP-R212 + C1-R212 placebo + C2-R212 placebo

C1-R212 group

DP-R212 placebo + C1-R212 + C2-R212 placebo

Group Type ACTIVE_COMPARATOR

C1-R212

Intervention Type DRUG

DP-R212 placebo + C1-R212 + C2-R212 placebo

C2-R212 group

DP-R212 placebo + C1-R212 placebo + C2-R212

Group Type ACTIVE_COMPARATOR

C2-R212

Intervention Type DRUG

DP-R212 placebo + C1-R212 placebo + C2-R212

Interventions

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DP-R212

DP-R212 + C1-R212 placebo + C2-R212 placebo

Intervention Type DRUG

C1-R212

DP-R212 placebo + C1-R212 + C2-R212 placebo

Intervention Type DRUG

C2-R212

DP-R212 placebo + C1-R212 placebo + C2-R212

Intervention Type DRUG

Eligibility Criteria

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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
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

Other Identifiers

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DP-CTR212-III-03

Identifier Type: -

Identifier Source: org_study_id

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