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Claims for Patent: 8,183,295

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Claims for Patent: 8,183,295

Title:Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Abstract: The invention relates to a pharmaceutical composition comprising (i) a renin inhibitor, (ii) a calcium channel blocker (CCB), and a diuretic and to a method of using such composition for the treatment of cardiovascular disease.
Inventor(s): Feldman; David L (Teaneck, NJ), Webb; Randy L (Flemington, NJ)
Assignee: Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Application Number:12/188,604
Patent Claims: 1. A pharmaceutical composition consisting of (i) 150-500 mg aliskiren or a pharmaceutically acceptable salt thereof, (ii) 1.0-40 mg amlodipine or a pharmaceutically acceptable salt thereof, (iii) 5-200 mg hydrochlorothiazide, and one or more pharmaceutically acceptable carriers, wherein the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide administered in combination achieve a greater therapeutic effect than the therapeutic effects achievable with the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide administered alone.

2. A pharmaceutical composition according to claim 1, wherein the amount of amlodipine or a pharmaceutically acceptable salt thereof is from 2.5 to 25 mg.

3. A pharmaceutical composition according to claim 2, wherein the amount of hydrochlorothiazide is from 5 to 25 mg.

4. A pharmaceutical composition according to claim 1, wherein the amount of hydrochlorothiazide is from 5 to 25 mg.

5. A pharmaceutical composition consisting of: (i) 150-500 mg aliskiren or a pharmaceutically acceptable salt thereof, (ii) 1.0-40 mg amlodipine or a pharmaceutically acceptable salt thereof, and (iii) 5-200 mg hydrochlorothiazide, and one or more pharmaceutically acceptable carriers, wherein the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide are administered in a unit dosage form, said combination achieving a greater therapeutic effect than the therapeutic effects achievable with the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide administered alone.

6. A pharmaceutical composition consisting of: (i) 140-220 mg aliskiren or a pharmaceutically acceptable salt thereof, (ii) 2.0-12 mg amlodipine or a pharmaceutically acceptable salt thereof, and (iii) 5-15 mg hydrochlorothiazide, and one or more pharmaceutically acceptable carriers, wherein the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide are administered in a unit dosage form, said combination achieving a greater therapeutic effect than the therapeutic effects achievable with the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide administered alone.

7. A pharmaceutical composition consisting of: (i) 550-700 mg aliskiren or a pharmaceutically acceptable salt thereof, (ii) 2.0-12 mg amlodipine or a pharmaceutically acceptable salt thereof, and (iii) 5-30 mg hydrochlorothiazide, and one or more pharmaceutically acceptable carriers, wherein the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide are administered in a unit dosage form, said combination achieving a greater therapeutic effect than the therapeutic effects achievable with the amounts of (i) aliskiren or a pharmaceutically acceptable salt thereof, (ii) amlodipine or a pharmaceutically acceptable salt thereof and (iii) hydrochlorothiazide administered alone.
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