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

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

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00444834

Enrollment

Registered

2007-03-08

Start date

2007-04-30

Completion date

2007-05-31

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGCarvedilol

50 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026