EUCTR2012-001945-42-GB
Active, not recruiting
Phase 1
A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the effects of intravenous serelaxin infusion on micro- and macrovascular function in patients with coronary artery disease
ovartis Pharma Service AG0 sites58 target enrollmentStarted: August 19, 2013Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Service AG
- Enrollment
- 58
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Male and female patients \=18 years of age, with body weight \<160 kg.
- •Patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non\-invasive clinical imaging assessments (e.g. stress\-echo, PET or SPECT myocardial perfusion), or invasive coronary angiography or by CT coronary angiography at any point in time in patients with or without mild left ventricular systolic
- •dysfunction (LVSD).
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Previous treatment with serelaxin (also known as: RLX030, relaxin)
- •Women of child\-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment.
- •Current or planned dialysis.
- •Impaired renal function during screening defined as an estimated glomerular filtration rate (eGFR) at screening and prior to treatment of \<30 mL/min/1\.73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation due to potential issue with administration of GdDTPA used as the MRI contrast agent.
- •Sick\-Sinus\-Syndrome
- •Current or history of pulmonary edema, including suspected sepsis.
- •Known significant valvular disease (including any of the following: severe aortic stenosis \[AVA \< 1\.0 or peak gradient \> 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis).
- •Clinical diagnosis of acute coronary syndrome (ACS) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria
- •Troponin elevation and dynamics indicative of ACS at any time between screening and randomization.
- •Previous myocardial infarction within 3 months of screening
Investigators
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