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

2014-08-27 03:16:35 | BioPortfolio

Summary

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 the change in body weight from baseline at the time of the final administration will be compared between the two groups.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cirrhosis

Intervention

OPC-41061, Placebo

Location

Chubu Region
Japan

Status

Recruiting

Source

Otsuka Pharmaceutical Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:35-0400

Clinical Trials [328 Associated Clinical Trials listed on BioPortfolio]

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

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 an...

A Double-Blind, Placebo-Controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despi...

A Dose-Finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-...

A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.

PubMed Articles [1363 Associated PubMed Articles listed on BioPortfolio]

Economic burden of cirrhosis in Catalonia: a population-based analysis.

Cirrhosis is a chronic disease with high morbidity and mortality. Few studies have evaluated healthcare resource use in patients with cirrhosis.

Increased Morbidity and Mortality Associated with Falls among Patients with Cirrhosis.

Injuries are more morbid and complicated to manage in patients with cirrhosis. However, data are limited regarding the relative risk of injury and severity of injury from falls in patients with cirrho...

The Challenges of Nutritional Assessment in Cirrhosis.

Nutritional status in patients with cirrhosis is very frequently associated with macro- and micronutrient deficiencies. Cirrhosis itself is the cause of malnutrition and nutritional deficiencies but t...

Advanced cirrhosis drives enhanced B-cell differentiation resulting in hyperglobulinemia.

The mechanism underlying hyperglobulinemia in cirrhosis, a long appreciated phenomenon, has never been clearly understood. The aim of this study is to investigate the basis for changes in humoral immu...

Immature platelet fraction and thrombopoietin in patients with liver cirrhosis: A cohort study.

Thrombocytopenia occurs frequently in patients with cirrhosis. The immature platelet fraction (IPF%) is measured to differentiate the causes of thrombocytopenia. To date the relevance of thrombopoieti...

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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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

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