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A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Taiwan Otsuka Pharm. Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT01618448
First received: June 5, 2012
Last updated: January 15, 2013
Last verified: January 2013

June 5, 2012
January 15, 2013
July 2012
January 2013   (final data collection date for primary outcome measure)
Change in body weight at 4-day of treatment. [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01618448 on ClinicalTrials.gov Archive Site
  • Change in Intake/Output Balance at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • Change in Serum Sodium and Potassium Concentration at 4-day of treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • Treatment Failure at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • Changes in Physician-assessed Signs and Symptoms of Heart Failure at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • Changes in Patient Self-assessed Global Clinical Status at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • Changes in Patient Self-assessed Dyspnea Status at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ] [ Designated as safety issue: No ]
  • All-cause Mortality during the Study Period [ Time Frame: Duration of hospital stay for 4 days, post-study follow up visit for 2 times ] [ Designated as safety issue: Yes ]
    Total timeframe expected average of 37 days for each participant
Same as current
Not Provided
Not Provided
 
A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure
A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart Failure

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiac-induced Edema
  • Drug: Tolvaptan
    Tolvaptan 15mg once daily
  • Drug: Placebo
    Placebo
  • Experimental: Placebo
    Placebo once daily
    Intervention: Drug: Placebo
  • Experimental: Tolvaptan
    Tolvaptan 15mg once daily
    Intervention: Drug: Tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
December 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients aged 20 to 85 years old, inclusive, at the Screening Period
  2. Patients with history of chronic HF hospitalized primarily for worsening HF with signs or symptoms of volume congestion in spite of standard therapy
  3. Patient should have HF symptoms at rest or minimal exertion and signs of congestion (lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion) at time of randomization c. Anti-aldosterone drugs: Spironolactone, Triamterene
  4. Patients undergoing any of the following diuretic therapies:

    • 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)

    Note: The allowable types and dosages of the concomitantly administered diuretics are specified as follows:

    1. Loop diuretics equivalent to 40 mg of furosemide:

      Bumetanide: 1 mg, Piretanide: 6 mg, Azosemide: 60 mg, Torasemide: 8 mg

    2. Thiazide diuretics: Hydrochlorothiazide, Trichloromethiazide, Benzyl hydrochlorothiazide, Chlortalidone, Mefruside
  5. Patients who had been taking an orally administered diuretic without any change in dose or mode of administration during Observation period
  6. Patients whose body weight variation was within 1.0 kg during the 2 days prior start of treatment
  7. Patients able to accomplish with study procedures from Screening period to Post-study follow-up
  8. Patients capable of giving informed consent to participate in the study of their own free will.

Exclusion Criteria:

  1. Cardiac surgery within 60 days of enrollment
  2. Patients with an assisted cardiac mechanical device
  3. Patients receiving CRT (Cardiac Resynchronization Therapy) within 60 days of enrollment.
  4. Patients with active or significant complications or symptoms as follow:

    • Suspected decrease in circulatory blood flow
    • Refractory end-stage HF (patients considered to require mechanical circulatory support, continuous intravenous positive inotropic therapy, referral of cardiac transplantation, or hospice care)
    • Cardiac valvular disease with significant heart valve stenosis
    • Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to screening examination
    • Acute myocardial infarction within 30 days prior to screening examination
    • Cerebrovascular disorders within 6 months prior to screening examination (other than asymptomatic cerebral infarction)
    • Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
    • Poorly controlled Diabetes Mellitus (HbAlc 10%)
    • Anuria (urinary output less than 100 ml per day)
    • History of Hyperthyroidism
    • Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
    • Hemofiltration or dialysis
    • Patients unable to sense thirst, inappropriately respond to thirst or those who have impaired oral fluid intake.
  5. Patients with a history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
  6. Patients who are severely obese (BMI exceeding 35 kg/m2)
  7. Patients with systolic blood pressure in the decubitus position below 90 mmHg
  8. Patients with any of following abnormal laboratory values:

    Total bilirubin exceeding 3.0 mg/dL, hemoglobin of less than 9 g/dL, serum creatinine exceeding 3.0 mg/dL, serum sodium exceeding 147 mEq/L, or serum potassium exceeding 5.5 mEq/L

  9. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
  10. Patients who received any investigational drug other than Tolvaptan within 30 days prior to the screening examination
  11. Patients with general physical conditions, which may confound the results of the study, pose additional risk or preclude evaluation and assessments in this study
Both
20 Years to 85 Years
No
Contact: Edward Peng (+)886-2-2505-2868 ext 317 edward_peng@otsuka.co.tw
Taiwan
 
NCT01618448
156-TWA-1101
No
Taiwan Otsuka Pharm. Co., Ltd
Taiwan Otsuka Pharm. Co., Ltd
Not Provided
Not Provided
Taiwan Otsuka Pharm. Co., Ltd
January 2013

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