A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00525265 | Completed Phase 3 Results

• 1 other identifier: 156-06-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.

Conditions

Cardiac Edema

Keywords

Vasopressin antagonist; Cardiac Edema; Diuretics

Outcome Measures

Primary Outcomes (1)

• Body Weight

  The body weight change from baseline at the time of final trial drug administration

  Baseline, at the time of final trial drug administration

Study Arms (2)

1

EXPERIMENTAL

OPC-41061

Drug: OPC-41061(Tolvaptan)

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

OPC-41061(Tolvaptan) DRUG

Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.

1

Placebo DRUG

Subjects will be orally administered placebo once daily after breakfast for seven days.

2

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 treatments 7 days prior to the start of treatment.
• Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
• CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
• Male or female subjects between the age of 20 and 85, inclusive.
• Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2.
• Subjects capable of giving informed consent to participate in the study of their own free will.

You may not qualify if:

• Subjects with heart failure with markedly fluctuating symptoms.
• Subjects with an assisted circulation device.
• Subjects with any of the following complications or symptoms:(1)Suspected decrease in circulatory blood flow,(2)Hypertrophic cardiomyopathy (other than dilated phase),(3)Cardiac valve disease with significant heart valve stenosis,(4)Hepatic coma.
• Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
• Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
• Subjects with any of the following complications or symptoms:(1)Diabetes mellitus with poorly controlled blood glucose,(2)Anuria,(3)Urination impaired due to urinary tract stricture,urinary calculus,tumor in urinary tract,or other cause.
• Subjects with a history of any of the following diseases:(1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator,(2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),(3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives.
• Subjects who are morbidly obese (body mass index exceeding 35).
• Subjects with systolic blood pressure in the decubitus position below 90 mmHg.
• Subjects with any of the following abnormal laboratory values:(1)Total bilirubin \> 3.0 mg/dL,(2) serum creatinine \> 3.0 mg/dL,(3)serum sodium \> 147 mEq/L,(4)serum potassium \> 5.5 mEq/L.
• Subjects who are unable to take oral medication.
• Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
• Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
• Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2007
• First Posted: September 5, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 25, 2013
• Results First Posted: December 25, 2013

Record last verified: 2013-11

Locations

JP (2)