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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

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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 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 [1327 Associated PubMed Articles listed on BioPortfolio]

The Conundrum of Cryptogenic Cirrhosis: Adverse Outcomes without Treatment Options.

Although patients with cryptogenic cirrhosis have been historically considered to have "burnt out" nonalcoholic steatohepatitis (NASH), some controversy remains. The aim was to compare outcomes of pat...

Placebo analgesia persists during sleep: An experimental study.

Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...

Using Placebo Beverages in Group Alcohol Studies.

Placebo beverage conditions remain a key element in the methodological toolkit for alcohol researchers interested in evaluating pharmacological and nonpharmacological factors influencing the effects o...

Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects.

Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.

Role of the von Willebrand factor and the VITRO score as predictors for variceal bleeding in patients with hepatitis C-related cirrhosis.

Noninvasive methods have been established to detect clinically significant portal hypertension in liver cirrhosis with variable limitations. The von Willebrand factor (vEF) has been found to increase ...

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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