UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006859 |
|---|---|
| Receipt number | R000008111 |
| Scientific Title | A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment |
| Date of disclosure of the study information | 2011/12/08 |
| Last modified on | 2013/06/08 09:39:30 |
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Basic information
Public title
A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment
Acronym
A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment
Scientific Title
A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment
Scientific Title:Acronym
A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetics and Pharmacodynamics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma concentration, Cmax,AUC24h,AUCt, tmax, t1/2 of tolvaptan on day 1 and 7
Key secondary outcomes
urine volume, fluid intake, clinical laboratory tests of serum chemistry and urine chemistry, serum BNP, serum AVP, body weight, congestive symptom and safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan 15mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)patients who are already administered diuretics at least 3 days prior to tolvaptan's administration
(2)patients who can keep using fixed-dose furosemide (40-200mg)
(3)congestive heart failure patients who have lower limb edema, pulmonary congestion or jugular venous distention due to volume overload
(4)subjects whose eGFR are under 45 mL/min/1.73m2
(5)male or female subjects between 20-85 years of age at the time of informed consent
(6)inpatient
(7)ability to provide written informed consent
Key exclusion criteria
(1)history of allergy against this drug or similar compounds
(2)patients who cannot feel thirsty or have difficulty to drink
(3)patients who have difficulty to peroral drug administration
(4)patients whose HF symptoms are remarkably unstable
(5)patients who have circulation assist
(6)patients who have disease, complication or symptom as follows;
possibly hypovolemic
*systolic blood pressure<90mmHg
*hypertrophic cardiomyopathy
*active myocarditis or amyloid cardiomyopathy
*severe valvular cardiopathy
*severe diabetes
*body mass index (BMI)>35
*anuria (urine volume<100ml/day)
*impairment of urinary excretion due to urinary stenosis, calculus or tumor
*hepatic coma
*subjects who are pregnant or possibly pregnant
(7)patients who have a history as follows;
*a history of sustained ventricular tachycardia or ventricular fibrillation in patients who do not have ICD
*a history of cerebrovascular disease within 6 months (except for asymptomatic ischemic stroke )
*a history of acute myocardial infarction within 30 days
(8)patients whose laboratory tests are as follows;
*serum Na>147mEq/L
*serum K>5.5mEq/L
*T.B>3.0mg/dL
(9)patients who are judged to be inappropriate to this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenjiro Kimura |
Organization
St. Marianna University Hospital
Division name
Renal Disease Integrated Care Center
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yugo Shibagaki |
Organization
St. Marianna University Hospital
Division name
Renal Disease Integrated Care Center
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 08 | Day |
Last modified on
| 2013 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008111
