Status:
COMPLETED
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Heart Failure
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01439009
Start Date
September 1 2011
End Date
March 1 2014
Last Update
October 22 2019
Active Locations (8)
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1
Chube Region, Japan
2
Chushikoku Region, Japan
3
Hokkaido Region, Japan
4
Hokuriku Region, Japan