24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (\>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy.
Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally
Age
65–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase
You may not be if
Significant and/or unstable systemic illnesses
Allergy or hypersensitivity to risperidone or paliperidone
Significant risk of suicidal or violent behavior
Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant
Clareo Health | 24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
