Cardiac EdemaPhase 3NCT00525265
A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
A Phase 3 study testing OPC-41061(Tolvaptan) in people with Cardiac Edema, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in Japan.
Trial summary
To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients… 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)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2007to Jan 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 treatments 7 days prior to the start of treatment.
- Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
- CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- Male or female subjects between the age of 20 and 85, inclusive.
- Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2.
- Subjects capable of giving informed consent to participate in the study of their own free will.
Who cannot join
- Subjects with heart failure with markedly fluctuating symptoms.
- Subjects with an assisted circulation device.
- Subjects 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,(4)Hepatic coma.
- Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
- Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
- Subjects with any of the following complications or symptoms:(1)Diabetes mellitus with poorly controlled blood glucose,(2)Anuria,(3)Urination impaired due to urinary tract stricture,urinary calculus,tumor in urinary tract,or other cause.
Show all 15Show fewer
- Subjects with a history of any of the following diseases:(1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator,(2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),(3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives.
- Subjects who are morbidly obese (body mass index exceeding 35).
- Subjects with systolic blood pressure in the decubitus position below 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.
- Subjects who are unable to take oral medication.
- Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
- Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
- Subjects who previously participated in this or any other study of OPC-41061 and received OPC-41061.
- Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
Trial locations and contacts
2 sites in 1 country.
About this study
To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
- Conditions
- Cardiac Edema
- Being tested
- OPC-41061(Tolvaptan), Placebo
- 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
Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
PlaceboDrug
Subjects will be orally administered placebo once daily after breakfast for seven days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OPC-41061 Receives: Drug: OPC-41061(Tolvaptan) |
| 2 | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The body weight change from baseline at the time of final trial drug administration
Measured: Baseline, at the time of final trial drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT00525265
- Sponsor's protocol ID
- 156-06-004
- Status last verified
- Nov 2013
- First submitted
- 3 Sep 2007
- Last updated
- 25 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
- ClinicalTrials.gov ID
- NCT00525265
- Acronym / sponsor ID
- 156-06-004
- Conditions
- Cardiac Edema
- Keywords
- Vasopressin antagonist, Cardiac Edema, Diuretics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 25 Dec 2013
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 pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
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 |
|---|---|---|
| 1 | Experimental | Drug: OPC-41061(Tolvaptan)OPC-41061 |
| 2 | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
- Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
- CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- Male or female subjects between the age of 20 and 85, inclusive.
- Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2.
Key exclusion criteria (15 listed)
- Subjects with heart failure with markedly fluctuating symptoms.
- Subjects with an assisted circulation device.
- Subjects 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,(4)Hepatic coma.
- Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
- Subjects with well-defined 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)Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. | Drug | 1 |
| PlaceboSubjects will be orally administered placebo once daily after breakfast for seven days. | Drug | 2 |
Primary outcome
Body Weight
Time frame: Baseline, at the time of final trial drug administration
The body weight change from baseline at the time of final trial drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cardiac Edema
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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
2 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 2 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 6 inclusion and 15 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 25 Dec 2013). 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, at the time of final trial 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 25 Dec 2013.