Cardiac EdemaPhase 3NCT00544869
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
A Phase 3 study testing OPC-41061 （Tolvaptan) in people with Cardiac Edema, run by Otsuka Pharmaceutical Co., Ltd. at 6 sites in Japan.
Trial summary
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF)… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cardiac Edema
- What is being tested?
- OPC-41061 （Tolvaptan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesJapan
- Study dates
- Oct 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with cardiac edema receiving diuretic treatment since 7 days prior to the commencement of study drug administration.
- Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
- 1. A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
- 2. Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
- 3. Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
- CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
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- Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
- Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
- Subjects capable of giving informed consent to participate in the study of their own free will
Who cannot join
- Heart failure patients with markedly fluctuating symptoms
- Patients with an assisted circulation device
- Patients with any of the following complications or symptoms:
- 1. Suspected decrease in circulatory blood flow ，
- 2. Hypertrophic cardiomyopathy (other than dilated phase)，
- 3. Cardiac valve disease with significant heart valve stenosis，
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- 4. Hepatic coma
- Patients who develop acute myocardial infarction within 30 days prior to the screening examination
- Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
- Subjects with any of the following complications or symptoms:
- 1. Poorly controlled diabetes melllitus，
- 2. Anuria，
- 3. Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Subjects with any of the following disease histories:
- 1. Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in subjects without an implanted defibrillator，
- 2. Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction)，
- 3. A history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride.
- Subjects who are severely obese [body mass index (BMI, body weight (kg)/height (m)2] exceeding 35]
- Subjects with systolic blood pressure in the decubitus position exceeding 90 mmHg
- Subjects with any of the following abnormal laboratory values:
- 1. Total bilirubin > 3.0 mg/dL,
- 2. serum creatinine > 3.0 mg/dL,
- 3. serum sodium > 147 mEq/L,
- 4. serum potassium > 5.5 mEq/L
- Patients who are unable to take oral medication
- Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant during the study period
- Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination
- Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chubu Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyuush
Study site
Shikoku Region
About this study
Official title: Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.
- Conditions
- Cardiac Edema
- Being tested
- OPC-41061 （Tolvaptan)
- Keywords
- Vasopressin antagonist , Cardiac Edema ,Diuretics
- Medical subject headings
- Edema, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-41061 （Tolvaptan)Drug
15-30mg/day,daily for 14days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: OPC-41061 （Tolvaptan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The change of body weight from baseline at final observation
Measured: Baseline, Day 14 or at the time of final drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac EdemaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, Division of New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544869
- Sponsor's protocol ID
- 156-06-006
- Status last verified
- Dec 2013
- First submitted
- 15 Oct 2007
- Last updated
- 30 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg
- ClinicalTrials.gov ID
- NCT00544869
- Acronym / sponsor ID
- 156-06-006
- Conditions
- Cardiac Edema
- Keywords
- Vasopressin antagonist , Cardiac Edema ,Diuretics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OPC-41061 （Tolvaptan) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with cardiac edema receiving diuretic treatment since 7 days prior to the commencement of study drug administration.
- Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
- CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
- Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
Key exclusion criteria (28 listed)
- Heart failure patients with markedly fluctuating symptoms
- Patients with an assisted circulation device
- Patients with any of the following complications or symptoms:
- Patients who develop acute myocardial infarction within 30 days prior to the screening examination
- Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
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 |
|---|---|---|
| OPC-41061 （Tolvaptan)15-30mg/day,daily for 14days | Drug | 1 |
Primary outcome
Body Weight
Time frame: Baseline, Day 14 or at the time of final drug administration
The change of body weight from baseline at final observation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
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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.
Katsuhisa Saito study director
Division of New Product Evaluation and Development
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPC-41061 （Tolvaptan) in people with Cardiac Edema, run by Otsuka Pharmaceutical Co., Ltd. at 6 sites in Japan.
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 9 inclusion and 28 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Weight (time frame: Baseline, Day 14 or at the time of final drug administration). 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 30 Jan 2014.