Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

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. Identifier: NCT01439009
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : July 11, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Tolvaptan Drug: Placebo of tolvaptan Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center,_double-blind,_pararel-group Comparison Trial to Investigate the Effect of Short-term Administration of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients (Phase_4 Study)
Study Start Date : September 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: Tolvaptan
15 mg
Drug: Tolvaptan
Once-daily oral administration of one tolvaptan 15 mg tablet in the morning

Placebo Comparator: Placebo
Drug: Placebo of tolvaptan
Once-daily oral administration of one placebo tablet in the morning

Primary Outcome Measures :
  1. mid- or long-term prognosis [ Time Frame: Week 26 ]
  2. Adverse events [ Time Frame: Week 26 ]
  3. clinical laboratory tests [ Time Frame: Week26 ]
  4. vital signs [ Time Frame: Week26 ]
  5. 12-lead ECG [ Time Frame: Week26 ]
  6. M-mode echocardiography [ Time Frame: Week 26 ]
  7. mortality [ Time Frame: Week26 ]
  8. Body weight [ Time Frame: Day15 ]
  9. lower limb edema [ Time Frame: Day15 ]
  10. jugular venous distension [ Time Frame: Day15 ]
  11. hepatomegaly [ Time Frame: Day15 ]
  12. pulmonary rales [ Time Frame: Day15 ]
  13. third heart sound [ Time Frame: Day15 ]
  14. cardiothoracic ratio [ Time Frame: Day15 ]
  15. pulmonary congestion [ Time Frame: Day15 ]
  16. New York Heart Association (NYHA) Classification [ Time Frame: Day15 ]
  17. plasma brain natriuretic peptide (BNP) concentration [ Time Frame: Day15 ]
  18. dypnea [ Time Frame: Day15 ]

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients from whom informed consent has been properly obtained in writing prior to start of the trial
  • Patients who have been clinically diagnosed with heart failure
  • Patients with any of the following conditions or symptoms: lower limb edema, dyspnea, jugular venous distension, hepatomegaly, pulmonary rales, third heart sound, or pulmonary congestion
  • Patients who have been receiving loop diuretics, thiazide diuretics, or anti-aldosterone diuretics
  • Male or female patients of age 20 to 85 years inclusive (at time of informed consent)
  • Patients who, together with their partner(s), are able to use an appropriate method of contraception until 3 months after final trial drug administration
  • Patients who are able to be hospitalized at the trial site for at least 7 days from the start of trial drug administration

Exclusion Criteria:

  • Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
  • Patients with anuria
  • Patients who cannot sense thirst or who have difficulty with fluid intake
  • Patients with hypernatremia (serum sodium concentration > institutional upper limit of normal) 5) Female patients who are pregnant, possibly pregnant, or nursing
  • Patients judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial due to any of the following conditions or symptoms:

    • Hyponatremia (serum sodium concentration < 125 mEq/L)
    • Serious coronary artery disease or cerebrovascular disease
    • Hyperkalemia
    • Severe renal disorder
    • Poorly controlled diabetes mellitus
    • Severe hepatic disease
    • Impaired urinary excretion due to urinary stenosis, calculus, or tumor
    • Cardiac valve disease with significant heart valve stenosis
    • Malignant tumor of unfavorable prognosis
  • Patients with suspected hypovolemia
  • Patients with an implanted circulatory support device
  • Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
  • Patients who participated in any other clinical trial or postmarketing clinical trial within 30 days prior to the date of informed consent for the present trial
  • Patients who received tolvaptan within 26 weeks prior to the date of informed consent
  • Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01439009

Chube Region, Japan
Chushikoku Region, Japan
Hokkaido Region, Japan
Hokuriku Region, Japan
Kansai Region, Japan
Kanto Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01439009     History of Changes
Other Study ID Numbers: 156-10-005
JapicCTI-111621 ( Other Identifier: JAPIC )
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Heart failure
Volume overload
loop diuretics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs