Who is sponsoring NCT00145171?

NCT00145171 is sponsored by Mylan Bertek Pharmaceuticals.

What condition does NCT00145171 study?

NCT00145171 studies Parkinson Disease.

What drugs are being tested in NCT00145171?

Interventions: apomorphine HCl injection.

What is the status of NCT00145171?

NCT00145171 is currently COMPLETED.

Last reviewed 2005-09-02 · How we verify

Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson's Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg.

NCT00145171 Phase 3 COMPLETED

APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before.

Details

Lead sponsor	Mylan Bertek Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	56
Start date	2001-02
Completion	2002-08

Conditions

Parkinson Disease

Interventions

apomorphine HCl injection

Primary outcomes

Entire Study:
Adverse event assessments
For Crossover portion of placebo-controlled 4mg dose comparison:
Change in Unified Parkinson's Disease Rating Scale (UPDRS) at 20 minutes after dosing