Clinical Trial Results:
Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension
(Shorttitle: SIPHT)
Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months
Summary
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EudraCT number |
2005-004863-41 |
Trial protocol |
DE |
Global completion date |
31 Jan 2009
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Jul 2021
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First version publication date |
14 Jul 2021
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Other versions |
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Summary report(s) |
Final publication |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.