Edema, CardiacPhase 3NCT00462670
A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
A Phase 3 study testing OPC-41061(Tolvaptan) in people with Edema, Cardiac, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial summary
To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Edema, Cardiac
- What is being tested?
- OPC-41061(Tolvaptan)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2007to Oct 2008
- 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 receiving one of the following diuretic treatments (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 Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination.
- Male or female subjects age 20 or older and younger than 85 (at time of informed consent)
- Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 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
- Subjects with acute heart failure
- 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 a definite 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 such as mozavaptan hydrochloride or benazepril hydrochloride.
- Subjects who are obese [body mass index (BMI, body weight (kg)/height (m)2 exceeding 35]
- Patients with supine systolic blood pressure exceeding 90 mmHg
- Subjects with any of following abnormal laboratory values: (1)Total bilirubin exceeding 3.0 mg/dL, (2)serum creatinine exceeding 3.0 mg/dL, (3)serum sodium exceeding 147 mEq/L, (4)serum potassium exceeding 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
- 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
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.
- Conditions
- Edema, Cardiac
- Being tested
- OPC-41061(Tolvaptan)
- Keywords
- Cardiac edema, OPC-41061, Vasopressin antagonist
- 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
0, 15mg of OPC-41061 per day for 7days p.o. administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0mg Receives: Drug: OPC-41061(Tolvaptan) |
| 2 | Experimental | 15mg OPC-41061 Receives: Drug: OPC-41061(Tolvaptan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (Amount of Change)
Change in body weight from baseline at the time of final trial drug administration
Measured: baseline, Day 7 or at the time of final trial drug administration
Secondary outcomes (1)
Body Weight (Percent Change)
Percent change in body weight from baseline at the time of final trial drug administration
Measured: baseline, Day 7 or 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 posted19 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionOct 2008
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 Edema, CardiacStudies 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
- 110 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
- NCT00462670
- Sponsor's protocol ID
- 156-06-002
- Status last verified
- Dec 2013
- First submitted
- 17 Apr 2007
- Last updated
- 4 Feb 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 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
- ClinicalTrials.gov ID
- NCT00462670
- Acronym / sponsor ID
- 156-06-002
- Conditions
- Edema, Cardiac
- Keywords
- Cardiac edema, OPC-41061, Vasopressin antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional 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 | Placebo comparator | Drug: OPC-41061(Tolvaptan)0mg |
| 2 | Experimental | Drug: OPC-41061(Tolvaptan)15mg OPC-41061 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects receiving one of the following diuretic treatments (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 Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination.
- Male or female subjects age 20 or older and younger than 85 (at time of informed consent)
- Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 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
Key exclusion criteria (15 listed)
- Subjects with acute heart failure
- 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 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)0, 15mg of OPC-41061 per day for 7days p.o. administration | Drug | 1, 2 |
Primary outcome
Body Weight (Amount of Change)
Time frame: baseline, Day 7 or at the time of final trial drug administration
Change in body weight from baseline at the time of final trial drug administration
1 secondary outcome
Body Weight (Percent Change)
Time frame: baseline, Day 7 or 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 4 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
8 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 Edema, Cardiac, run by Otsuka Pharmaceutical Co., Ltd. at 8 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 5 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 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 4 Feb 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 (Amount of Change) (time frame: baseline, Day 7 or 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 4 Feb 2014.