A Study of Controlled-Release Carvedilol Compared to Imme... | NCT00444834

Studies
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension

NCT00444834

Sponsor

Egalet Ltd

Status

Terminated

Last Update Posted

Aug 29, 2016Estimated

Enrollment

14Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

Carvedilol

Countries

Denmark

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

ID	Type	Description	Link
EudraCT no.: 2006-006534-17

Official Title

A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IMP supply

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Mar 7, 2007

First Submission Date that Met QC Criteria

Mar 7, 2007

First Posted Date

Mar 8, 2007Estimated

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

Aug 26, 2016

Last Update Posted Date

Aug 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Egalet carvedilol	Drug: Carvedilol
2	Active Comparator	Coreg	Drug: Carvedilol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carvedilol	Drug	50 mg	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise		15w

Secondary Outcomes

Measure	Description	Time Frame
The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise		15w
Safety		15w

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of mild or moderate primary hypertension
Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
Be minimum 18 years of age

Exclusion Criteria:

Be intolerant to alfa- or beta-blockers
Have secondary causes of hypertension
Be taking more than two antihypertensive medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine Andersen, MSc Pharm	Egalet A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 02		Esbjerg			Denmark
Site 01

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077261	Carvedilol

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided