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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by (Responsible Party): | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00463320 |
Purpose
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 |
|---|---|---|
|
Macular Degeneration Age-related Macular Degeneration |
Drug: Pazopanib eye drops and Allergen Refresh Plus eye drops |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| 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 |
Eligibility| 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.
Contacts and Locations| 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 | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00463320 History of Changes |
| Other Study ID Numbers: | MD7108238 |
| Study First Received: | April 18, 2007 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Age-related macular degeneration (AMD), vascular endothelial growth factor (VEGF)receptor (VEGFR) choroidal neovascularization, |
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |