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 - NA

• Conditions: Hypertension; MedDRA version: 8.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2006-006534-17-DK
• Lead Sponsor: Egalet a/s

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

To be eligible for enrollment into this study, a patient MUST:
•Provide written informed consent.
•Be > 18 years of age.
•Be currently using an approved form of birth control if a female of child-bearing potential.
•Have a diagnosis of mild or moderate primary hypertension with (1) seated SBP > 140 and < 179 mmHg, AND (2) seated diastolic blood pressure (DBP) > 90 and < 114 mmHg. Patients with either a seated SBP or a seated DBP outside of these specified ranges will not be included.
•Be able to tolerate a 2-week Washout Phase followed by a 2-week Placebo Run-In Phase with no antihypertensive medication treatment.
•Be willing and able to maintain current dietary and exercise regimens throughout the study.
•Be willing and able to comply with all protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for enrollment into this study, a patient MUST NOT:
•Be taking more than two antihypertensive medications.
•Be a female who is pregnant or lactating.
•Have secondary causes of hypertension, as assessed by the Investigator.
•Have a clinical history of stroke or transient ischemic attacks.
•Have a clinical history of myocardial infarction or symptomatic angina pectoris within past six months.
•Have a current diagnosis of congestive heart failure or history of congestive heart failure requiring treatment or hospitalization.
•Have second or third degree heart block or other clinically relevant arrhythmia.
•Have Grade 3 or 4 hypertensive retinopathy.
•Have clinically significant renal or hepatic disease.
•Have a mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
•Be intolerant to alfa- or beta-blockers as a result of asthma or other forms of reversible, obstructive bronchial diseases.
•Work nightshift hours or conduct activities likely to disrupt normal circadian rythms.
•Have a clinical history of any disease state or surgery known to affect the gastrointestinal absorption of drugs.
•Have a clinical history or condition which, in the judgment of the Investigator, precludes safe treatment with CRC or IRC.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified