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(12) Patent Application Publication (10) Pub. No.: US 2004/0242565 A1 Toshima Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2004/0242565 A1 Toshima Et Al US 2004O242565A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0242565 A1 Toshima et al. (43) Pub. Date: Dec. 2, 2004 (54) MEDICINAL COMPOSITION FOR (57) ABSTRACT PREVENTION OF OR TREATMENT FOR A pharmaceutical composition comprising at least one of CEREBROWASCULAR DISORDER AND components (a) and at least one of components (b) shown in CARDOPATHY below: (76) Inventors: Yoshinori Toshima, Shizuoka (JP); (a) a compound represented by the general formula (I) Asako Hitomi, Shizuoka (JP); (I) Shin-ichi Satoh, Shizuoka (JP); Ichiro Ikegaki, Shizuoka (JP) r SON NH Correspondence Address: BRCH STEWART KOLASCH & BRCH N PO BOX 747 FALLS CHURCH, VA 22040-0747 (US) 2N (21) Appl. No.: 10/488,699 R1 (22) PCT Fed: Jul. 30, 2002 (wherein R1 represents a hydrogen atom or a hydroxyl (86) PCT No.: PCT/JP02/07712 group) or an acid addition Salt or hydrate thereof, and (b) an ameliorant of cerebral circulation, a vasodilator, a cerebral protecting drug, an brain metabolic Stimu (30) Foreign Application Priority Data lants, an anticoagulant, an antiplatelet drug, a throm bolytic drug, an amelirant of psychiatric Symptom, a Sep. 11, 2001 (JP)...................................... 2001-274846 antihypertensive drug, an antianginal drug, a diuretic, a cardiotonic, an antiarrhythmic drug, an antihyperlipidemic drug, an immunosuppreSSant, or Publication Classification a pharmaceutically acceptable Salt (except the com ponents shown in (a)). It is useful as a preventive or (51) Int. Cl. ............................................. A61K 31/551 remedy for cerebrovascular disorders and cardiac (52) U.S. Cl. .............................................................. 514/218 diseases. US 2004/0242565 A1 Dec. 2, 2004 MEDICINAL COMPOSITION FOR PREVENTION immunosuppressant until the pharmaceutical composition of OF OR TREATMENT FOR CEREBROWASCULAR the present invention is disclosed. DISORDER AND CARDIOPATHY DISCLOSURE OF THE INVENTION TECHNICAL FIELD 0006 An object of the present invention is to provide a 0001) The present invention relates to a pharmaceutical pharmaceutical composition that has a marked effect than composition that is effective against prevention or treatment that obtained when a preventive drug or a treatment drug is of diseases Such as a cerebrovascular disorder and a cardiac administered singly for prevention or treatment of a cere disease. brovascular disorder, a cardiac disease, and the like. 0007. In view of the above-mentioned circumstances, the RELATED ART inventors of the present invention have found that the 0002 For prevention or treatment of diseases such as a compound represented by the general formula (I) exerts cerebrovascular disorder and a cardiac disease, there have particularly significant effect that was not obtained when been used drugs such as an ameliorant of cerebral circula administering the compound singly for, e.g., drug effect, tion, a vasodilator, a cerebral protecting drug, an brain Safeness, stability, dosage, dosage form, usage, or the like by metabolic stimulants, an anticoagulant, an antiplatelet drug, using the compound in combination with an ameliorant of a thrombolytic drug, an amelirant of psychiatric symptom, a cerebral circulation, avasodilator, an cerebral protecting antihypertensive drug, an antianginal drug, a diuretic, a drug, an brain metabolic stimulants, an anticoagulant, an cardiotonic, an antiarrhythmic drug, an antihyperlipidemic antiplatelet drug, a thrombolytic drug, an amelirant of psy drug, and an immunosuppressant. chiatric Symptom, a antihypertensive drug, an antianginal drug, a diuretic, a cardiotonic, an antiarrhythmic drug, an 0003) On the other hand, it has been already known that antihyperlipidemic drug, or an immunosuppressant. Thus, a compound represented by the general formula (I): the inventors have accomplished the present invention based on the knowledge. (I) 0008 That is, the present invention relates to the follow r ings: SON NH 0009 (1) A pharmaceutical composition including at least one of components (a) and at least one of components N (b) shown in below. 0010) (a) A compound represented byy the following 2N. general formula (I): r (I) 0004 (wherein R1 represents a hydrogen atom or a SON NH hydroxyl group) has an inhibitory activity against a kinase Such as a Rho kinase, a myosin light chain kinase, or a protein kinase C, shows a vascular N Smooth muscle relaxation effect, a blood flow increasing effect, an antihypertensive effect, a cere 2N. bral protective effect, a cardiac protective effect, or the like; and is an effective Substance in a vasodilator R1 agent (particularly as a treating agent for angina), a cerebral protecting agent, a cardiac protecting agent, or the like (for example, JP 61-227581 A, JP 0011) (wherein R1 represents a hydrogen atom or a 02-256617 A, JP 06-056668A, JP 07-080854B, EP hydroxyl group) 0187371, WO 98/06433, Br. J. Pharmacol., 98, 1091 0012 (b) An ameliorant of cerebral circulation, a (1989), J. Pharmacol. Exp. Ther..., 259, 738 (1991), Vasodilator, a cerebral protecting drug, an brain Circulation, 96, 4357 (1997), Cardiovasc. Res., 43, metabolic stimulants, an anticoagulant, an antiplate 1029 (1999)). let drug, a thrombolytic drug, an amelirant of psy 0005. In the aforementioned documents, the single use of chiatric Symptom, a antihypertensive drug, an anti the compound represented by the general formula (I) is anginal drug, a diuretic, a cardiotonic, an disclosed. However, there have been no report regarding antiarrhythmic drug, an antihyperlipidemic drug, and concomitant use or a plan of concomitant use of the com an immunosuppressant (except the components pound with an ameliorant of cerebral circulation, a vasodi shown in (a)). lator, a cerebral protecting drug, an brain metabolic stimu 0013 Note that, in the present invention, the components lants, an anticoagulant, an antiplatelet drug, a thrombolytic (a) include, in addition to the compound represented by the drug, an amelirant of psychiatric Symptom, a antihyperten general formula (I), hydrates thereof (for example, 1/2 Sive drug, an antianginal drug, a diuretic, a cardiotonic, an hydrates, 1 hydrates, and 3 hydrates) and acid addition salts antiarrhythmic drug, an antihyperlipidemic drug, or an thereof. US 2004/0242565 A1 Dec. 2, 2004 0014) Moreover, the drug of components (b), which is and psychiatric Symptom, neurologic Symptom, disorder in used together with the component (a) represented by the activities of daily living disability, amnesia, and dementia, general formula (I) according to the present invention, which are based on those diseases. includes pharmaceutically acceptable Salts thereof. 0027 (14) The pharmaceutical composition according to 0.015 (2) The pharmaceutical composition according to item (12), in which the cerebrovascular disorder is selected item (1), in which the vasodilator shown in (b) is a calcium from the group consisting of cerebral infarction and cere channel blocking drug and the calcium channel blocking bral vasospasm; and a neurologic Symptom and disorder in drug is nimodipine. activities of daily living disability, which are based on those 0016 (3) The pharmaceutical composition according to diseases. item (1), in which the thrombolytic drug shown in (b) is a 0028 (15) The pharmaceutical composition according to tissue plasminogen activator and the tissue plasminogen item (12), in which the cerebrovascular disorder is selected activator is alteplase. from the group consisting of cerebral vasospasm developed 0017 (4) The pharmaceutical composition according to after Subarachnoid hemorrhage; and neurologic Symptom item (1), in which the antiplatelet drug shown in (b) is and disorder in activities of daily living disability, which are clopidogrel or aspirin. asSociated with those diseases. 0018 (5) The pharmaceutical composition according to 0029 (16) The pharmaceutical composition according to item (1), in which the antianginal drug shown in (b) is a item (3), which is provided for prevention or treatment of a calcium channel blocking drug and the calcium channel cerebrovascular disorder. blocking drug is amlodipine or nifedipine. 0030) (17) The pharmaceutical composition according to item (16) in which the cerebrovascular disorder is selected 0019 (6) The pharmaceutical composition according to from the group consisting of cerebral infarction, cerebral item (1), in which the antianginal drug shown in (b) is a thrombosis, celebral embolism, and transient ischemic nitrate drug and the nitrate drug is isosorbide. attack, and neurologic Symptom and disorder in activities of 0020 (7) The pharmaceutical composition according to daily living disability, which are based on those diseases. item (1), in which the antianginal drug shown in (b) is a 0031 (18) The pharmaceutical composition according to B-adrenaline receptor antagonist and the B-adrenaline recep item (4), which is provided for prevention or treatment of a tor antagonist is atenolol. cerebrovascular disorder. 0021 (8) The pharmaceutical composition according to 0032 (19) The pharmaceutical composition according to item (1), which is provided for prevention or treatment of a item (18), in which the cerebrovascular disorder is selected cerebrovascular disorder. from the group consisting of cerebral infarction, cerebral 0022 (9) The pharmaceutical composition according to thrombosis, celebral embolism, cerebral hemorrhage, cere item (8), in which the cerebrovascular accident is selected bral vasospasm, Subarachnoid hemorrhage, transient from the group consisting
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