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.

1 - 2 . (canceled) 
     
     
         3 . A pharmaceutical composition consisting of
 (i) 1-300 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 1.0-10 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 5-25 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. 
     
     
         4 . The pharmaceutical composition of claim  1 , consisting of
 (i) 75-225 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 2.5-7.5 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 6.0-18 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         5 . The pharmaceutical composition of claim  2 , consisting of
 (i) 125-175 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 4.0-6.0 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 10.5-14.4 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         6 . A pharmaceutical composition consisting of
 (i) 1-600 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 1.0-20 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 5-50 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. 
     
     
         7 . The pharmaceutical composition of  claim 4 , consisting of
 (i) 150-450 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 2.5-7.5 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 6.0-18 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         8 . The pharmaceutical composition of  claim 5 , consisting of
 (i) 250-350 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 4.0-6.0 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 10.5-14.5 mg hydrochlorothiazide and one or more pharmaceutically acceptable carriers.   
     
     
         9 . The pharmaceutical composition of  claim 4 , consisting of
 (i) 150-450 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 2.5-7.5 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 12.5-37.5 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         10 . The pharmaceutical composition of  claim 7 , consisting of
 (i) 250-350 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 4.0-6.0 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 20-30 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         11 . The pharmaceutical composition of  claim 4 , consisting of
 (i) 150-450 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 5.0-15 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 6.0-18 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         12 . The pharmaceutical composition of  claim 9 , consisting of
 (i) 250-350 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 7.5-12.5 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 10.5-14.5 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         13 . The pharmaceutical composition of  claim 4 , consisting of
 (i) 150-450 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 5.0-15 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 12.5-37.5 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         14 . The pharmaceutical composition of  claim 11 , consisting of
 (i) 250-350 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 7.5-12.5 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 20-30 mg hydrochlorothiazide   
       and one or more pharmaceutically acceptable carriers. 
     
     
         15 . A method of lowering blood pressure in a hypertensive mammal by administering a pharmaceutical composition consisting of
 (i) 1-300 mg aliskiren or a pharmaceutically acceptable salt thereof;   (ii) 1.0-10 mg amlodipine or a pharmaceutically acceptable salt thereof; and   (iii) 5-25 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.