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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00463320 |
This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly subjects.
Condition | Intervention | Phase |
---|---|---|
Age-Related Macular Degeneration |
Drug: Pazopanib eye drops and Allergen Refresh Plus eye drops |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Parallel Assignment, Safety Study |
Official Title: | A Placebo-Controlled, Randomized, Dose Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Ocular Doses of Pazopanib in Healthy Adult and Elderly Subjects. |
Enrollment: | 29 |
Study Start Date: | March 2007 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 30 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required:
(Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)
Exclusion criteria:
Medical history or condition:
Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator.
A condition or situation which, in the opinion of the investigator, may result in significant risk to the patient, confound the study results or interfere significantly with participation.
United States, North Dakota | |
GSK Investigational Site | |
Fargo, North Dakota, United States, 58104 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78744 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MD7108238 |
Study First Received: | April 18, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00463320 |
Health Authority: | United States: Food and Drug Administration |
Age-related macular degeneration (AMD), choroidal neovascularization, vascular endothelial growth factor (VEGF)receptor (VEGFR) |
Pseudoephedrine Eye Diseases Macular Degeneration Retinal Degeneration Healthy Tetrahydrozoline Endothelial Growth Factors Choroidal Neovascularization Naphazoline |
Oxymetazoline Guaifenesin Phenylephrine Ephedrine Phenylpropanolamine Neovascularization, Pathologic Retinal Diseases Retinal degeneration |
Respiratory System Agents Autonomic Agents Sympathomimetics Therapeutic Uses Physiological Effects of Drugs |
Vasoconstrictor Agents Cardiovascular Agents Peripheral Nervous System Agents Pharmacologic Actions Nasal Decongestants |