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A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients with Advanced Solid ...

Update Il y a 4 ans
Reference: EUCTR2005-003442-33

A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients with Advanced Solid Tumours

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Extract

In order to investigate the hypothesis that withdrawal of AZD2171 can be avoided by controlled anti-hypertensive therapy, the primary objective of the study is to identify a treatment strategy, consisting of a dose of AZD2171 and a hypertension management strategy (pre-defined management of emergent hypertension ± prophylaxis) that is well tolerated without significant drug withdrawal or dose reduction during the first 12 weeks of therapy with AZD2171.

Inclusion criteria

  • Management of AZD2171-induced hypertension in patients with advanced solid tumours

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