XOMA HTN 5400
Perindopril Amlodipine for the Treatment of Hyupertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluation the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate versus Perindopril Erbumine and Amplodipine Besylate in Subjects with Essential Hypertension
| Protocol | X985400 |
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| Identifier | X985400 |
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| UID | 0bd3401e-0151-49dc-8142-f680d9c853ad |
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| Status | Done - Archived |
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| Phase | 3 |
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| Category | Hypertension / Adult |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-03-28 12:55 |
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| Last Updated | 2012-03-28 12:55 |
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Description
Key Elements:
• Study drug XOMA 985 is a combination of two already approved drugs. Perindopril (Coversyl®) and Amlodipine (Norvasc®) are both used to treat HTN and heart disease. The efficacy of the study drug will be compared to the two components of the study drug separately. There will be three arms, and all subject will be receving active drug. There is no placebo.
• Study drug administration: 1 capsule once daily
• 4 Visits over 42 days/6 weeks
• Stipend TBA
• Subject will need to washout (14-21 days) off any HTN medications they are currently taking. If naïve they can be randomized as early as 7 days after Screening.
• Mean seated SBP must be < 180 mmHg at Screening and Visit 2. Mean DBP must be =95 mmHg and =115 mmHg at Visit 2 in order to qualify.
Comment
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