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Trial: NCT01624636 [RDF]

Label NCT01624636
Slug nct01624636
Trialid NCT01624636
Lookup name NCT01624636
Provenance http://clinicaltrials.gov/show/NCT01624636?displayxml=true
Lastchanged date June 20, 2012
Firstreceived results date
Firstreceived date May 3, 2012
Id info nct id NCT01624636
Overall status Not yet recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 59
Number of arms 3
Is section 801 Yes
Is fda regulated Yes
Brief title Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD)
Acronym
Official title A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration
Study type Interventional
Id info nct alias
Completion date
Verification date June 2012
Why stopped
Id info org study id CLFG316A2201
Required header url http://clinicaltrials.gov/show/NCT01624636
Study design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Source Novartis
Primary completion date August 2013
Brief summary
Number of groups
Required header download date Information obtained from ClinicalTrials.gov on June 21, 2012
Phase Phase 2
Start date August 2012
Has expanded access No
Biospec descr
Detailed description
Condition browse 6f7d84c9719028f3e316e9abd0a93e2a
Intervention browse None
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact Novartis Pharmaceuticals (Contact)
Overall contact backup None
Sponsor group 90f644cb72ad34536128c56de21732be
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility 9d57ee3c7ac5042329085ea693063336
Keywords Age-Related Macular Degeneration, AMD, Neovascular AMD, wet AMD
Conditions Neovascular Age-Related Macular Degeneration
Locations 561291c13688cc2cea1b18aaad17b91a, a5dbc8e9b837aa4dc3347e2478be2697, d4e85c2e3f2d0f1c94f0df36586145ba, ff3a5b3c63ec7e960325ce77d1cbd4a6
Links None
Results references None
Arm groups LFG316: 10 mg/kg (2 doses in cohort 1) (Arm Group), Placebo (Arm Group), LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2). (Arm Group)
Location countries United States
Interventions Placebo (Intervention), LFG316 (Intervention), LFG316 (Intervention)
Secondary outcomes 2cb5f67b26278ea633669e0a35967557, 60e8b8f19bf37b314b1653065c634e2d, dd5360aabcce6bd986e7618ec62b23dc, f1dca0ee8524728b3736521e5684d8a8
References None
Primary outcomes da0799e9eee690776728e23aa6d183a4, dd1f26e3e512e995274689f9d3ac417e
Removed countries None
Overall officials ce6f1ec7e2d96d33ee29897d454d967d