HyponatremiaPhase 3NCT00380575
Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study testing YM087 in people with Hyponatremia, run by Cumberland Pharmaceuticals at 47 sites in 4 countries.
Trial summary
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- YM087
- How many people
- 84 participants
- Where
- 47 sitesin 4 countries
- Study dates
- Aug 2000to Feb 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum sodium levels 115 to < 130mEq/L
- Euvolemic or Hypervolemic hyponatremia
Who cannot join
- Clinical evidence of volume depletion or dehydration
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
- Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
Trial locations and contacts
47 sites in 4 countries.
47 sites in 4 countries
United States27 sites
Study site
Chattanooga, Tennessee
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Huntington, West Virginia
Study site
Indianapolis, Indiana
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Mobile, Alabama
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Petoskey, Michigan
Study site
Phoenix, Arizona
Study site
Plantation, Florida
Study site
Rolla, Missouri
Study site
Salem, Virginia
Study site
Santa Rosa, California
Study site
Shreveport, Louisiana
Study site
Sioux Falls, South Dakota
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
Tuscon, Arizona
Study site
Worchester, Massachusetts
Israel9 sites
Study site
Ashkelon
Study site
Beersheba
Study site
Haifa 2 Sites
Study site
Holon
Study site
Jerusalem
Study site
Rehovot
Study site
Safed
Study site
Tel Aviv
Study site
Tel HaShomer
South Africa9 sites
Study site
Bloemfontein
Study site
Buff
Study site
Durban
Study site
East London
Study site
eManzimtoti
Study site
Johannesburg
Study site
Lyttelton Manor
Study site
Port Elizabeth
Study site
Pretoria
Canada2 sites
Study site
Drummondville, Quebec
Study site
Montreal 2 Sites, Quebec
About this study
Official title: A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
- Conditions
- Hyponatremia
- Being tested
- YM087
- Keywords
- hyponatremia, hypervolemic, euvolemic, vasopressins, YM087
- Medical subject headings
- Hyponatremia, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM087Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startAug 2000
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies 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
- Double blind
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380575
- Sponsor's protocol ID
- 087-CL-027
- Status last verified
- Apr 2014
- First submitted
- 22 Sep 2006
- Last updated
- 2 May 2014
- Results posted
- No
Publications
Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. doi: 10.1159/000106456. Epub 2007 Jul 26.
PubMed 17664863Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. doi: 10.1111/j.1365-2265.2007.03149.x. Epub 2008 Jul 1.
PubMed 18034777
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT00380575
- Acronym / sponsor ID
- 087-CL-027
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, hypervolemic, euvolemic, vasopressins, YM087
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Aug 2000
- Study completion
- Feb 2003 (actual)
- First posted
- 26 Sep 2006 (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.
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Serum sodium levels 115 to < 130mEq/L
- Euvolemic or Hypervolemic hyponatremia
Key exclusion criteria (3 listed)
- Clinical evidence of volume depletion or dehydration
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
- Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
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 |
|---|---|---|
| YM087 | Drug | – |
Primary outcome
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
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 May 2014.
- Background: PubMed 17664863Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. doi: 10.1159/000106456. Epub 2007 Jul 26.
- Background: PubMed 18034777Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. doi: 10.1111/j.1365-2265.2007.03149.x. Epub 2008 Jul 1.
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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.
Art Wheeler, MD study director
Cumberland Pharmaceuticals
47 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM087 in people with Hyponatremia, run by Cumberland Pharmaceuticals at 47 sites in 4 countries.
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 2 inclusion and 3 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Israel, South Africa, Canada. 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?
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380575, which also lists 2 linked publications.
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 May 2014.