Model-Supported Development of CS-8635: A Fixed-Dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

Autor:	Shashank Rohatagi, Helen Moore, Reinilde Heyrman, SaeHeum Song, Michelle Green, Raymond Miller, Timothy J. Carrothers, James Lee, Michael Melino, Daniel E. Salazar, Antonia Wang, Manini Patel
Rok vydání:	2013
Předmět:	business.industry Fixed-dose combination Pharmaceutical Science Pharmacology Clinical study Hydrochlorothiazide Blood pressure medicine Triple combination Pharmacology (medical) In patient Amlodipine business Olmesartan medicine.drug
Zdroj:	Clinical Pharmacology in Drug Development. 2:103-112
ISSN:	2160-763X
DOI:	10.1002/cpdd.17
Popis:	CS-8635, a fixed-dose triple combination of olmesartan, amlodipine, and hydrochlorothiazide, was developed to address the growing need for additional blood pressure (BP) reduction in patients not controlled with dual-combination therapies. Prior to Phase III, modeling and simulation (MS CS-8635 plus two prior dual combinations. M&S robustly estimated and described the BP lowering effects of CS-8635 evaluated in a clinical setting. Furthermore, M&S evaluated BP lowering effects of the additional four dose strengths not studied. In summary, M&S aided the development of the clinical study and full characterization of the BP lowering effects of CS-8635 across intermediate doses.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::6b55fd7f812b63ff305ba02e447a5756 https://doi.org/10.1002/cpdd.17 Zobrazit plný text záznamu Plný text