Cardiac-induced EdemaPhase 3NCT01618448
Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure
A Phase 3 study testing Tolvaptan in people with Cardiac-induced Edema, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cardiac-induced Edema
- What is being tested?
- Tolvaptan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Loop diuretics equivalent to 40 mg of furosemide:
- Bumetanide: 1 mg, Piretanide: 6 mg, Azosemide: 60 mg, Torasemide: 8 mg
- 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.
Who cannot join
- Cardiac surgery within 60 days of enrollment
- Patients with an assisted cardiac mechanical device
- Patients receiving CRT (Cardiac Resynchronization Therapy) within 60 days of enrollment.
- 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)
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- 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.
- Patients with a history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
- Patients who are severely obese (BMI exceeding 35 kg/m2)
- Patients with systolic blood pressure in the decubitus position below 90 mmHg
- 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
- Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
- Patients who received any investigational drug other than Tolvaptan within 30 days prior to the screening examination
- Patients with general physical conditions, which may confound the results of the study, pose additional risk or preclude evaluation and assessments in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Interventional, phase III, 2-arm parallel group, placebo-controlled, multicenter, randomized 1:1, double-blind study, comparing Tolvaptan and placebo in hospitalized HF patients with signs or symptoms of congestion at the time of randomization in spite of standard therapy.This study intends to demonstrate that a repeated 4-day treatment with Tolvaptan in addition to standard of care (SOC) is superior to SOC alone for the treatment of clinical relevant cardiac-induced volume retention parameters in patients hospitalized for worsening HF initially treated with conventional therapy including diuretics.
- Conditions
- Cardiac-induced Edema
- Being tested
- Tolvaptan, Placebo
- Medical subject headings
- Edema, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Tolvaptan 15mg once daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo once daily Receives: Drug: Placebo |
| Tolvaptan | Experimental | Tolvaptan 15mg once daily Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight at 4-day of treatment.
Measured: baseline and 4-day of treatment
Secondary outcomes (7)
Change in Intake/Output Balance at 4-day of Treatment
Measured: baseline and 4-day of treatment
Change in Serum Sodium and Potassium Concentration at 4-day of treatment
Measured: baseline and 4-day of treatment
Treatment Failure at 4-day of Treatment
Measured: baseline and 4-day of treatment
Changes in Physician-assessed Signs and Symptoms of Heart Failure at 4-day of Treatment
Measured: baseline and 4-day of treatment
Changes in Patient Self-assessed Global Clinical Status at 4-day of Treatment
Measured: baseline and 4-day of treatment
Changes in Patient Self-assessed Dyspnea Status at 4-day of Treatment
Measured: baseline and 4-day of treatment
All-cause Mortality during the Study Period
Total timeframe expected average of 37 days for each participant
Measured: Duration of hospital stay for 4 days, post-study follow up visit for 2 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac-induced EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuen-Den Tseng, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618448
- Sponsor's protocol ID
- 156-TWA-1101
- Status last verified
- Jan 2013
- First submitted
- 5 Jun 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01618448
- Acronym / sponsor ID
- 156-TWA-1101
- Conditions
- Cardiac-induced Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Interventional, phase III, 2-arm parallel group, placebo-controlled, multicenter, randomized 1:1, double-blind study, comparing Tolvaptan and placebo in hospitalized HF patients with signs or symptoms of congestion at the time of randomization in spite of standard therapy.This study intends to demonstrate that a repeated 4-day treatment with Tolvaptan in addition to standard of care (SOC) is superior to SOC alone for the treatment of clinical relevant cardiac-induced volume retention parameters in patients hospitalized for worsening HF initially treated with conventional therapy including diuretics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboPlacebo once daily |
| Tolvaptan | Experimental | Drug: TolvaptanTolvaptan 15mg once daily |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (25 listed)
- Cardiac surgery within 60 days of enrollment
- Patients with an assisted cardiac mechanical device
- Patients receiving CRT (Cardiac Resynchronization Therapy) within 60 days of enrollment.
- Patients with active or significant complications or symptoms as follow:
- Patients with a history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanAlso: SamscaTolvaptan 15mg once daily | Drug | Tolvaptan |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in body weight at 4-day of treatment.
Time frame: baseline and 4-day of treatment
7 secondary outcomes
Change in Intake/Output Balance at 4-day of Treatment
Time frame: baseline and 4-day of treatment
Change in Serum Sodium and Potassium Concentration at 4-day of treatment
Time frame: baseline and 4-day of treatment
Treatment Failure at 4-day of Treatment
Time frame: baseline and 4-day of treatment
Changes in Physician-assessed Signs and Symptoms of Heart Failure at 4-day of Treatment
Time frame: baseline and 4-day of treatment
Changes in Patient Self-assessed Global Clinical Status at 4-day of Treatment
Time frame: baseline and 4-day of treatment
Changes in Patient Self-assessed Dyspnea Status at 4-day of Treatment
Time frame: baseline and 4-day of treatment
All-cause Mortality during the Study Period
Time frame: Duration of hospital stay for 4 days, post-study follow up visit for 2 times
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuen-Den Tseng principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Cardiac-induced Edema, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight at 4-day of treatment. (time frame: baseline and 4-day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.