NCT00444834

Brief Summary

The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

March 7, 2007

Last Update Submit

August 26, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Egalet carvedilol

Drug: Carvedilol

2

ACTIVE COMPARATOR

Coreg

Drug: Carvedilol

Interventions

CarvedilolDRUG

50 mg

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 02

Esbjerg, Denmark

Location

Site 01

Frederiksberg, Denmark

Location

MeSH Terms

Conditions

Hypertension

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Christine Andersen, MSc Pharm

    Egalet A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 8, 2007

Study Start

April 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

DK(2)