Methods of improving myocardial performance in fontan patients using udenafil compositions

Abstract

The present invention relates generally to the field of using udenafil or a pharmaceutically acceptable salt thereof in patients who have undergone the Fontan operation.

1 - 30 . (canceled) 
     
     
         31 . A pharmaceutical composition for administration to a subject, said pharmaceutical composition comprising:
 udenafil, or a pharmaceutically acceptable salt thereof, in an amount of about 87.5 mg; and   a pharmaceutically acceptable excipient.   
     
     
         32 . The pharmaceutical composition of  claim 31 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         33 . The pharmaceutical composition of  claim 31 , wherein the pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a liquid, a liquid dispersion, a pill, a powder and a suspension. 
     
     
         35 . The pharmaceutical composition of  claim 31 , wherein the subject is a human, whose age ranges from about 12 to under about 18 years old. 
     
     
         36 . The pharmaceutical composition of  claim 35 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         37 . The pharmaceutical composition of  claim 31 , wherein the subject is a human, who is under about 18 years. 
     
     
         38 . The pharmaceutical composition of  claim 37 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         39 . A pharmaceutical composition for administration to a subject, said pharmaceutical composition comprising:
 udenafil, or a pharmaceutically acceptable salt thereof, in an amount of about 125 mg; and   a pharmaceutically acceptable excipient.   
     
     
         40 . The pharmaceutical composition of  claim 39 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         41 . The pharmaceutical composition of  claim 39 , wherein the pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         42 . The pharmaceutical composition of  claim 41 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a liquid, a liquid dispersion, a pill, a powder and a suspension. 
     
     
         43 . The pharmaceutical composition of  claim 39 , wherein the subject is a human, whose age ranges from about 12 to under about 18 years old. 
     
     
         44 . The pharmaceutical composition of  claim 43 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         45 . The pharmaceutical composition of  claim 39 , wherein the subject is a human, who is under about 18 years. 
     
     
         46 . The pharmaceutical composition of  claim 45 , wherein said pharmaceutical composition is an oral tablet. 
     
     
         47 . A pharmaceutical composition for oral administration to a subject born with single ventricle heart disease who has undergone Fontan surgery for improving, maintaining or reducing the rate of decline in a clinically relevant measurement that is indicative of the subject's health following the Fontan surgery or for increasing the likelihood of improving, maintaining or reducing the rate of decline in the clinically relevant measurement that is indicative of the subject's health following the Fontan surgery, said pharmaceutical composition comprising:
 udenafil, or a pharmaceutically acceptable salt thereof, in an amount of at least about 125 mg; and   a pharmaceutically acceptable excipient;   wherein, the subject is a human, whose age ranges between about 12 years old and under about 18 years old; and   wherein, the clinically relevant measurement is exercise capacity.   
     
     
         48 . The pharmaceutical composition of  claim 47 , wherein the udenafil, or a pharmaceutically acceptable salt thereof, is in an amount of about 87.5 mg, to be administered twice daily. 
     
     
         49 . The pharmaceutical composition of  claim 47 , wherein the pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         50 . The pharmaceutical composition of  claim 49 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a liquid, a liquid dispersion, a pill, a powder and a suspension. 
     
     
         51 . The pharmaceutical composition of  claim 47 , wherein the pharmaceutical composition is an oral tablet. 
     
     
         52 . A pharmaceutical composition for oral administration to a subject born with single ventricle heart disease who has undergone Fontan surgery for improving, maintaining or reducing the rate of decline in a clinically relevant measurement that is indicative of the subject's health following the Fontan surgery or for increasing the likelihood of improving, maintaining or reducing the rate of decline in the clinically relevant measurement that is indicative of the subject's health following the Fontan surgery, said pharmaceutical composition comprising:
 udenafil, or a pharmaceutically acceptable salt thereof, in an amount of at least about 125 mg; and   a pharmaceutically acceptable excipient;   wherein, the subject is a human, whose age ranges between about 12 years old and under about 18 years old; and   wherein, the clinically relevant measurement is exercise capacity.   
     
     
         53 . The pharmaceutical composition of  claim 52 , wherein the udenafil, or a pharmaceutically acceptable salt thereof, is in an amount of about 87.5 mg, to be administered twice daily. 
     
     
         54 . The pharmaceutical composition of  claim 52 , wherein the pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         55 . The pharmaceutical composition of  claim 54 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a pill, a suspension and a powder. 
     
     
         56 . The pharmaceutical composition of  claim 52 , wherein the pharmaceutical composition is an oral tablet. 
     
     
         57 . A pharmaceutical composition for oral administration to a subject born with single ventricle heart disease who has undergone Fontan surgery for improving, maintaining or reducing the rate of decline in a clinically relevant measurement that is indicative of the subject's health following the Fontan surgery or for increasing the likelihood of improving, maintaining or reducing the rate of decline in the clinically relevant measurement that is indicative of the subject's health following the Fontan surgery, said pharmaceutical composition comprising:
 udenafil, or a pharmaceutically acceptable salt thereof, in a therapeutically effective dose; and   a pharmaceutically acceptable excipient, for improving, maintaining or reducing the rate of decline in a clinically relevant measurement that is indicative of the subject's health following the Fontan surgery or for increasing the likelihood of improving, maintaining or reducing the rate of decline in the clinically relevant measurement that is indicative of the subject's health following the Fontan surgery in the subject;   wherein, the subject is a human, whose age ranges from about 12 to under about 18 years of age or older;   wherein, the therapeutically effective dose of udenafil, or a pharmaceutically acceptable salt thereof, is at least about 125 mg;   wherein, the pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition;   wherein, the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a pill, a suspension and a powder; and   wherein, the clinically relevant measurement is exercise capacity.   
     
     
         58 . The pharmaceutical composition of  claim 57 , wherein, the therapeutically effective dose of udenafil, or a pharmaceutically acceptable salt thereof, is about 87.5 mg, to be administered twice daily. 
     
     
         59 . An oral pharmaceutical composition for oral administration to a subject born with single ventricle heart disease who has undergone Fontan surgery for improving the subject's exercise capacity or increasing the likelihood of improving the subject's exercise capacity, wherein the subject's exercise capacity is indicative of the subject's health following the Fontan surgery, said oral pharmaceutical composition comprising:
 a therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof; and   a pharmaceutically acceptable excipient, for improving the exercise capacity or increasing the likelihood of improving the subject's exercise capacity;   wherein, the therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof, is at least about 125 mg; and   wherein, the subject is a human subject.   
     
     
         60 . The pharmaceutical composition of  claim 59 , wherein the therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof, is in an amount of about 87.5 mg, to be administered twice daily. 
     
     
         61 . The oral pharmaceutical composition of  claim 59 , wherein the oral pharmaceutical composition is a tablet. 
     
     
         62 . The oral pharmaceutical composition of  claim 59 , wherein the oral pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         63 . The oral pharmaceutical composition of  claim 62 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a liquid, a liquid dispersion, a pill, a powder and a suspension. 
     
     
         64 . An oral pharmaceutical composition for oral administration to a subject born with single ventricle heart disease who has undergone Fontan surgery for improving the subject's s exercise capacity or increasing the likelihood of improving the subject's exercise capacity, wherein the subject's exercise capacity is indicative of the subject's health following the Fontan surgery, said oral pharmaceutical composition comprising:
 a therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof; and   a pharmaceutically acceptable excipient, for improving the exercise capacity or increasing the likelihood of improving the subject's exercise capacity;   wherein, the therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof, is at least about 125 mg; and   wherein, the subject is a human subject.   
     
     
         65 . The pharmaceutical composition of  claim 64 , wherein the therapeutically effective amount of udenafil, or a pharmaceutically acceptable salt thereof, is in an amount of about 87.5 mg, to be administered twice daily. 
     
     
         66 . The oral pharmaceutical composition of  claim 64 , wherein the oral pharmaceutical composition is a tablet. 
     
     
         67 . The oral pharmaceutical composition of  claim 64 , wherein the oral pharmaceutical composition is a solid or semi-solid oral pharmaceutical composition. 
     
     
         68 . The oral pharmaceutical composition of  claim 67 , wherein the solid or semi-solid oral pharmaceutical composition is selected from a group of solid or semi-solid oral pharmaceutical compositions consisting of a tablet, a capsule, a gel, a pill, a suspension and a powder.