A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg

NCT01048788 | Completed Phase 3 Results

• 2 other identifiers: 156-08-002JapicCTI-100983
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

Brief Summary

OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy. Based on the change in body weight, on Day 7 it will be decided whether to continue administration at the same dose or to increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of OPC-41061 by 14-day repeated administration will be investigated.

Conditions

Cirrhosis

Keywords

Cirrhosis; ascites; Tolvaptan; OPC-41061

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Changes in body weight from baseline at the end of administration

  Baseline, Day 14 or end of administration

Study Arms (1)

OPC

EXPERIMENTAL

Drug: OPC-41061

Interventions

OPC-41061 DRUG

OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.

OPC

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients judged as having cirrhosis\* based on previous imaging diagnosis
• Definition of cirrhosis includes patients with collateral circulation due to chronic hepatic impairment
• Patients with ascites in whom the dose of existing diuretics cannot be increased due to risk of adverse drug reactions such as electrolyte abnormalities, or in whom sufficient therapeutic effect cannot be obtained with existing diuretics
• Patients who have been receiving oral combination therapy with a loop diuretic and an anti-aldosterone agent from at least 7 days prior to receipt of informed consent, with a dose combination of either loop diuretic equivalent to furosemide 40 mg/day or higher plus spironolactone 25 mg/day or higher, or loop diuretic equivalent to furosemide 20 mg/day or higher plus spironolactone 50 mg/day or higher
• Patients who are hospitalized or who can be hospitalized for the trial
• Patients capable of giving informed consent
• Patients who, together with their partner, agree to use an appropriate method of contraception until 4 weeks after the final trial drug administration

You may not qualify if:

• Patients with any of the following complications or symptoms:
• Hepatic encephalopathy (hepatic coma of grade 2 or higher)
• Hepatocellular carcinoma with imaging-diagnosed vascular infiltration into trunk or primary branch of portal vein, inferior vena cava, or trunk of hepatic vein
• Endoscopic findings from screening examination or from within 30 days prior to screening examination indicating the need for new therapy for esophageal or gastric varices during the trial period
• Repeated hemorrhoidal bleeding due to rectal varicose veins within 30 days prior to informed consent
• Heart failure (New York Heart Association Class III or IV)
• Anuria
• Impaired urination due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
• Patients with a history of any of the following disorders:
• Cerebrovascular disorder within 30 days prior to informed consent
• Hypersensitivity or idiosyncratic reaction to benzazepine derivatives (such as mozavaptan hydrochloride or benazepril hydrochloride)
• Morbidly obese patients with a body mass index (BMI: body weight (kg)/height (m)2) exceeding 35
• Patients with sitting systolic blood pressure lower than 90 mmHg
• Patients with any of following abnormal clinical laboratory values at time of the screening examination: Hemoglobin lower than 8.0 g/dL, total bilirubin higher than 4.0 mg/dL, serum creatinine higher than 2.0 mg/dL, serum sodium higher than 147 mEq/L, or serum potassium higher than 5.5 mEq/L
• Patients who are unable to take oral medication

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 14, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 11, 2016
• Results First Posted: March 4, 2014

Record last verified: 2016-03

Locations

JP (6)