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

Phase 2TerminatedNCT00444834

Egalet Ltd14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

CarvedilolDRUG

50 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Site 02

Esbjerg, Denmark

Site 01

Frederiksberg, Denmark

Outcomes

Primary Outcomes

The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise

Time frame: 15w

Secondary Outcomes

The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise

Time frame: 15w

Safety

Time frame: 15w

Data from ClinicalTrials.gov

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