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| Sponsored by: |
Merck |
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00449956 |
Purpose
The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension.
| Condition | Intervention | Phase |
|
Glaucoma |
Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: timolol maleate Drug: Comparator: dorzolamide hydrochloride |
Phase III |
| Genetics Home Reference related topics: | early-onset glaucoma |
| MedlinePlus related topics: | Glaucoma High Blood Pressure |
| ChemIDplus related topics: | Dorzolamide Dorzolamide hydrochloride Timolol Timolol maleate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Multicenter, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers |
| Enrollment: | 450 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
1: combination of dorzolamide hydrochloride and timolol maleate
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Drug: dorzolamide hydrochloride (+) timolol maleate
dorzolamide hydrochloride 1% + timolol maleate 0.5%, 8-week
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2
2: concomitant use of dorzolamide hydrochloride and timolol maleate
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Drug: Comparator: timolol maleate
timolol maleate 0.5%, 8-week
Drug: Comparator: dorzolamide hydrochloride
dorzolamide hydrochloride 1%, 8-week
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3: Active Comparator
3: timolol maleate
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Drug: Comparator: timolol maleate
timolol maleate 0.5%, 8-week
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Eligibility
| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_011, MK0507A-149 |
| First Received: | March 19, 2007 |
| Last Updated: | March 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00449956 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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