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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00525265
First received: September 3, 2007
Last updated: December 11, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Edema
 Drug: OPC-41061(Tolvaptan)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Resource links provided by NLM:

Drug Information available for: Tolvaptan
U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Pharmacological Outcome Variables(Urine volume, fluid intake, urine osmolality, quantitative examination,biochemical examination of blood, plasma AVP) [ Time Frame: after 7days treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OPC-41061
 Drug: OPC-41061(Tolvaptan)
Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
Placebo Comparator: 2
placebo
 Drug: Placebo
Subjects will be orally administered placebo once daily after breakfast for seven days.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
  2. 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.
  3. CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
  4. Male or female subjects between the age of 20 and 85, inclusive.
  5. 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.
  6. Subjects capable of giving informed consent to participate in the study of their own free will.

Exclusion Criteria:

  1. Subjects with heart failure with markedly fluctuating symptoms.
  2. Subjects with an assisted circulation device.
  3. 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.
  4. Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
  5. Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
  6. 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.
  7. 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.
  8. Subjects who are morbidly obese (body mass index exceeding 35).
  9. Subjects with systolic blood pressure in the decubitus position below 90 mmHg.
  10. 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.
  11. Subjects who are unable to take oral medication.
  12. Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
  13. Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
  14. Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061.
  15. Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525265

Locations
Japan
Kanto Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Katsuhisa Saito, OPCJ
ClinicalTrials.gov Identifier: NCT00525265     History of Changes
Other Study ID Numbers: 156-06-004
Study First Received: September 3, 2007
Last Updated: December 11, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Vasopressin antagonist
Cardiac Edema
Diuretics

Additional relevant MeSH terms:
Edema
Edema, Cardiac
Heart Failure
 Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013