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Clinical Trials/EUCTR2008-001306-16-BE
EUCTR2008-001306-16-BEActive, not recruitingPhase 1

A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy

ovartis Pharma Services AG0 sites800 target enrollmentStarted: June 10, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
800
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patients that complete the CSPP100A2340 Core” study through Visit 10, while
  • •on double-blind study drug.
  • •2. Patients who are able to participate in the study, and who consent to do so after
  • •the purpose and nature of the study has been clearly explained to them (written
  • •informed consent).
  • •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

  • •1. NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 ”Core” Study
  • •Visit 10).
  • •2. Symptomatic hypotension, or reported systolic BP < 90 mmHg within the 24 hours
  • •prior to Visit 1 (CSPP100A2340 ”Core” Study Visit 10).
  • •3. Known Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the
  • •MDRD formula at Visit 1 (CSPP100A2340 Core” Study Visit 10).
  • •4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
  • •of a female after conception and until the termination of gestation, confirmed by a
  • •positive hCG laboratory test (> 5 mIU/ml).
  • •5. Women of child-bearing potential (WOCBP), defined as all women physiologically
  • •capable of becoming pregnant, including women whose career, lifestyle, or sexual
  • •orientation precludes intercourse with a male partner and women whose
  • •partners have been sterilized by vasectomy or other means, UNLESS they meet
  • •the following definition of post-menopausal: 12 months of natural (spontaneous)
  • •amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels
  • •> 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without
  • •hysterectomy OR are using one or more of the following acceptable methods of
  • •contraception: surgical sterilization (e.g., bilateral or tubal ligation), hormonal
  • •contraception (implantable, patch, oral), and double-barrier methods (any double
  • •combination of: IUD, male or female condom with spermicidal gel, diaphragm,
  • •sponge, cervical cap) if accepted by local ethics committees. Reliable
  • •contraception should be maintained throughout the study and for at least 7 days
  • •after study drug discontinuation.
  • •6. Any surgical or medical condition that in the opinion of the investigator may place
  • •the patient at higher risk from his/her participation in the study or is likely to
  • •prevent the patient from complying with the requirements or completing the

Investigators

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