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Clinical Trials/EUCTR2009-009871-36-DE
EUCTR2009-009871-36-DE
Active, not recruiting
Not Applicable

Effect and Safety of preventive Treatment with ACE-Inhibitor and Beta-Blocker on the onset of Left Ventricular Dysfunction in Duchenne Muscular Dystrophy - DMD-Kardio

Friedrich- Alexander- Universität Erlangen Nürnberg0 sitesAugust 6, 2009
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ConditionsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsEnalHexal®, 5 mgEnaHexal®, 10mgMetoHEXAL® Succ ® 23,75 mg RetardtablettenMetoHEXAL® Succ ® 47,5 mg RetardtablettenMetoHEXAL® Succ ® 95 mg Retardtabletten

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Sponsor
Friedrich- Alexander- Universität Erlangen Nürnberg
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 6, 2009
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Male patients with DMD (confirmed by genetic analysis or muscle biopsy) • aged 10 – 14 years • Normal left ventricular function (fraction shortening \= 30%) • Normal renal function (GFR \> 30 ml/min/1,73 m2\) • Informed Consent of both parents, assent of patient
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 55
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Dilated left ventricle (size \> 97\. Percentile) or Left Ventricular Dysfunction (fraction shortening \<30%) • contraindications for ACE\-Inhibitors/Beta\-Blocker • previous therapy with ACE\-Inhibitors, AT II Antagonists, Beta\-Blockers • Other medical reasons which render participation not reasonable for the patient

Outcomes

Primary Outcomes

Not specified

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