HyponatremiaPhase 3NCT00492037
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study testing YM087 oral in people with Hyponatremia, run by Cumberland Pharmaceuticals at 29 sites in 9 countries.
Trial summary
Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- YM087 oral
- Type of treatment
- Pill or oral medicine
- How many people
- 83 participants
- Where
- 29 sitesin 9 countries
- Study dates
- Jan 2000to Feb 2002
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum Sodium 115 to <130mEq/L
- Plasma Osmolarity <290 mOsmol/kg H2O
Who cannot join
- Significant renal insufficiency
- Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
Germany5 sites
Study site
Bad Nauheim
Study site
Berlin
Study site
Dresdan
Study site
Göttingen
Study site
München
Netherlands4 sites
Study site
Delft
Study site
Groningen
Study site
Leiden
Study site
Nijmegen
About this study
Official title: A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia
- Conditions
- Hyponatremia
- Being tested
- YM087 oral
- Keywords
- hyponatremia, hypervolemic, euvolemic, conivaptan
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM087 oralDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum sodium from Baseline Safety of each dosing regimen
Measured: Beginning through end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJan 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parke-Davis
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492037
- Sponsor's protocol ID
- 087-CL-043
- Other IDs
- 1025-023
- Status last verified
- Apr 2014
- First submitted
- 25 Jun 2007
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
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 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT00492037
- Acronym / sponsor ID
- 087-CL-043
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, hypervolemic, euvolemic, conivaptan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Parke-Davis
- Study start
- Jan 2000
- Study completion
- Feb 2002 (actual)
- First posted
- 27 Jun 2007 (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.
Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Serum Sodium 115 to <130mEq/L
- Plasma Osmolarity <290 mOsmol/kg H2O
Key exclusion criteria (2 listed)
- Significant renal insufficiency
- Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)
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 oral | Drug | – |
Primary outcome
Change in serum sodium from Baseline Safety of each dosing regimen
Time frame: Beginning through end of treatment
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.
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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
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM087 oral in people with Hyponatremia, run by Cumberland Pharmaceuticals at 29 sites in 9 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 2 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 29 sites in Germany, Italy, Netherlands, Belgium, France and 4 more countries. 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 serum sodium from Baseline Safety of each dosing regimen (time frame: Beginning through end 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 May 2014.