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

NCT00544869 | Completed Phase 3 Results

• 1 other identifier: 156-06-006
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.

Conditions

Cardiac Edema

Keywords

Vasopressin antagonist , Cardiac Edema ,Diuretics

Outcome Measures

Primary Outcomes (1)

• Body Weight

  The change of body weight from baseline at final observation

  Baseline, Day 14 or at the time of final drug administration

Study Arms (1)

1

EXPERIMENTAL

Drug: OPC-41061 （Tolvaptan)

Interventions

OPC-41061 （Tolvaptan) DRUG

15-30mg/day,daily for 14days

1

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with cardiac edema receiving diuretic treatment since 7 days prior to the commencement of study drug administration.
• Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
• \. A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
• \. Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
• \. Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
• CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
• Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
• Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
• Subjects capable of giving informed consent to participate in the study of their own free will

You may not qualify if:

• Heart failure patients with markedly fluctuating symptoms
• Patients with an assisted circulation device
• Patients with any of the following complications or symptoms:
• \. Suspected decrease in circulatory blood flow ，
• \. Hypertrophic cardiomyopathy (other than dilated phase)，
• \. Cardiac valve disease with significant heart valve stenosis，
• \. Hepatic coma
• Patients who develop acute myocardial infarction within 30 days prior to the screening examination
• Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
• Subjects with any of the following complications or symptoms:
• \. Poorly controlled diabetes melllitus，
• \. Anuria，
• \. Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
• Subjects with any of the following disease histories:
• \. Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in subjects without an implanted defibrillator，

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyuush, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

MeSH Terms

Conditions

Edema, Cardiac

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; 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 Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7314

Study Officials

• Katsuhisa Saito

  Division of New Product Evaluation and Development

  STUDY DIRECTOR

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: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 30, 2014
• Results First Posted: January 30, 2014

Record last verified: 2013-12

Locations

JP (6)