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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525265
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 3, 2007
First Posted Date  ICMJE September 5, 2007
Results First Submitted Date  ICMJE November 1, 2013
Results First Posted Date  ICMJE December 25, 2013
Last Update Posted Date December 25, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
Body Weight [ Time Frame: Baseline, at the time of final trial drug administration ]
The body weight change from baseline at the time of final trial drug administration
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2007)
Pharmacological Outcome Variables(Urine volume, fluid intake, urine osmolality, quantitative examination,biochemical examination of blood, plasma AVP) [ Time Frame: after 7days treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Official Title  ICMJE A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Edema
Intervention  ICMJE
  • Drug: OPC-41061(Tolvaptan)
    Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
  • Drug: Placebo
    Subjects will be orally administered placebo once daily after breakfast for seven days.
Study Arms  ICMJE
  • Experimental: 1
    OPC-41061
    Intervention: Drug: OPC-41061(Tolvaptan)
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525265
Other Study ID Numbers  ICMJE 156-06-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP