Clinical Trial to Evaluate the Efficacy and Safety of DP-... | NCT02955368

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

NCT02955368

Sponsor

Alvogen Korea

Status

Withdrawn

Last Update Posted

Jun 5, 2017Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Hypertension
Hypercholesterolemia

Interventions

DP-R212
C1-R212
C2-R212

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Canceled

Expanded Access Info

Start Date

Feb 2017Estimated

Primary Completion Date

Jul 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2017

Last Update Posted Date

Jun 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DP-R212 group	Experimental	DP-R212 + C1-R212 placebo + C2-R212 placebo	Drug: DP-R212
C1-R212 group	Active Comparator	DP-R212 placebo + C1-R212 + C2-R212 placebo	Drug: C1-R212
C2-R212 group	Active Comparator	DP-R212 placebo + C1-R212 placebo + C2-R212	Drug: C2-R212

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DP-R212	Drug	DP-R212 + C1-R212 placebo + C2-R212 placebo	DP-R212 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change of LDL-Cholesterol		0, 8 weeks
Change of mean seated Systolic Blood Pressure		0, 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias

Browse Leaves

Not provided

Browse Branches

Not provided