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| Date: |
| Project: AZ 1000 | | | | |
| Indication: Hypertension | Formulation: Tablet |
| Product Attributes | |
| All attributes are minimum requirements | quan- titative | cer- tain | pro- bable | not clear |
| 1. Efficacy | | | | |
| * Significant responder rate (long-term treatment) | > 60 % | | * | |
| * Dose dependant efficacy | | | * | |
| * One well-tolerated dose should reduce diastolic blood pressure at trough compared to placebo by | > 8 mm Hg | | | |
| 2. Tolerability | | | | |
| * Risk/benefit ratio and incidence of adverse events at least comparable to ACEIs or Ca antagonists e.g.: | | | | |
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metabolically neutral |
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no narrow therapeutic index |
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no negative effects on electrolyte balance |
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no restrictions when combined with common drugs, particularly CV and MD |
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no major contraindications |
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no CNS side effects |
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| * (a) in contrast to Ca antagonists no clinically relevant peripheral edema or increase in heart rate | | | | |
| * (b) in contrast to ACE inhibitors no negative impact on lung (particularly no cough induction) and those renal conditions negatively affected by ACE inhibitors | | | | |
| 3. Convenience | | | | |
| * Once-a-day application | | | * | |
| * Small, easy to swallow oral formulation | | * | | |
| 4. Innovation (USP) | | | | |
| * Demonstration of 2a) or 2b) without additional adverse effect | | | | * |