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A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema

2014-08-27 03:14:01 | BioPortfolio

Summary

OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatm

Conditions

Cirrhosis

Intervention

OPC-41061, OPC-41061

Location

Tokyo, et al.
Japan

Status

Recruiting

Source

Otsuka Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:01-0400

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A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema

To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pl...

A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and th...

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A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

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ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be cont...

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Medical and Biotech [MESH] Definitions

Experimentally induced chronic injuries to the parenchymal cells in the liver to achieve a model for LIVER CIRRHOSIS.

FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cirrhosis involves the destruction of small intra-hepatic bile ducts and bile secretion. Secondary biliary cirrhosis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes.

FIBROSIS of the hepatic parenchyma due to chronic excess ALCOHOL DRINKING.

Abnormal increase of resistance to blood flow within the hepatic PORTAL SYSTEM, frequently seen in LIVER CIRRHOSIS and conditions with obstruction of the PORTAL VEIN.

Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.

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