Hypertension MedDRA version: 8.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: Carvedilol Egalet® Formulation
Pharmaceutical Form: Capsule*
INN or Proposed INN: Carvedilol
CAS Number: 72956-09-03
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Egalet a/s
Eligibility
Sex/Gender
All
Inclusion criteria
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 90 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of Egalet formulation of Controlled-Release Carvedilol (CRC) compared to Immediate-Release Carvedilol (IRC) after 3 weeks of treatment.;Secondary Objective: The secondary objective of this trial is to evaluate the safety and tolerability of CRC and IRC after 3 weeks of treatment.;Primary end point(s): The primary efficacy endpoint for this study is: •The change from baseline to 3 weeks treatment in systolic blood pressure (SBP) at the end of five minutes of sub-maximal exercise for the Egalet formulation of Controlled-Release Carvedilol (CRC) compared to Immediate-Release Carvedilol (IRC). | — |
Countries
Denmark
Outcome results
None listed