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

This study is currently recruiting participants.
Verified April 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01439009
First received: September 15, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Heart Failure
Drug: Tolvaptan
Drug: Placebo of tolvaptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • mid- or long-term prognosis [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • clinical laboratory tests [ Time Frame: Week26 ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: Week26 ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: Week26 ] [ Designated as safety issue: Yes ]
  • M-mode echocardiography [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: Week26 ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • lower limb edema [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • jugular venous distension [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • hepatomegaly [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • pulmonary rales [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • third heart sound [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • cardiothoracic ratio [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • pulmonary congestion [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • New York Heart Association (NYHA) Classification [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • plasma brain natriuretic peptide (BNP) concentration [ Time Frame: Day15 ] [ Designated as safety issue: No ]
  • dypnea [ Time Frame: Day15 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan
15 mg
Drug: Tolvaptan
Once-daily oral administration of one tolvaptan 15 mg tablet in the morning
Placebo Comparator: Placebo
Placebo
Drug: Placebo of tolvaptan
Once-daily oral administration of one placebo tablet in the morning

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439009

Contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Japan
Recruiting
Chube Region, Japan
Recruiting
Chushikoku Region, Japan
Recruiting
Hokkaido Region, Japan
Recruiting
Hokuriku Region, Japan
Recruiting
Kansai Region, Japan
Recruiting
Kanto Region, Japan
Contact: -         
Recruiting
Kyushu Region, Japan
Recruiting
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01439009     History of Changes
Other Study ID Numbers: 156-10-005, JapicCTI-111621
Study First Received: September 15, 2011
Last Updated: April 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014