A study to assess the efficacy, safety and tolerability of PF-04950615 following monthly and twice monthly injection dosing for six months in subjects on a statin with high cholesterol

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-001226-10

Femme et Homme

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Extrait

To evaluate the LDL-C lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in hypercholesterolemic subjects whose LDL-cholesterol is ≥80 mg/dL on background treatment with a statin. Subjects will be randomized into 7 parallel groups. Five of these groups will receive PF 04950615 while two groups will receive placebo. PF 04950615 will be administered as different doses for each dose group in order to examine a dose or exposure response to study outcomes. Eligible subjects will be randomly assigned to a study treatment group in equal numbers per group, to receive PF 04950615 300mg once every 28 days (Q28D), 200mg once every 28 days (Q28D), placebo once every 28 days (Q28D), 150mg every 14 days (Q14D), 100 mg every 14 days (Q14D), 50 mg every 14 days (Q14D), or placebo every 14 days (Q14D). Additional information regarding Study Treatments is in Clinical Protocol Section 5.


Critère d'inclusion

  • Hyperlipidemia

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