HyponatremiaPhase 3NCT00379847
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study testing conivaptan in people with Hyponatremia, run by Cumberland Pharmaceuticals at 28 sites in 3 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?
- conivaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 28 sitesin 3 countries
- Study dates
- Feb 2004to Jun 2005
- 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 less than or equal 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
28 sites in 3 countries.
28 sites in 3 countries
Israel11 sites
Study site
Afula
Study site
Ashkelon
Study site
Hadera
2 Sites
Haifa
Study site
Holon
2 Sites
Jerusalem
Study site
Nahariya
Study site
Rehovot
2 Sites
Safed
Study site
Tel Aviv
Study site
Tsrifin
South Africa10 sites
Study site
Amanzimototi
Study site
Bellville
Study site
Bloemfontein
2 Sites
Durban
4 Sites
Johannesburg
Study site
Krugersdorp
Study site
Lyttelton
Study site
Pretoria
Study site
Somerset West
Study site
Soweto
United States7 sites
Study site
Augusta, Georgia, 30901
Study site
Cincinnati, Ohio, 45219
Study site
Columbia, South Carolina, 29209
Study site
Denver, Colorado, 80262
Study site
Petoskey, Michigan, 49700
Study site
Tuscon, Arizona, 85723
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 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
- conivaptan
- Keywords
- hyponatremia, hypervolemic, euvolemic, treatment outcomes, YM087
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conivaptanDrug
Also called Vaprisol, YM087
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lower dose Receives: Drug: conivaptan |
| 2 | Experimental | Higher dose Receives: Drug: conivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted change in AUC for serum sodium
Measured: 96 Hours
Secondary outcomes (1)
Comparison of safety between patients in each study arm
Measured: 96 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startFeb 2004
- Primary completionJun 2005
- Study completionJun 2005
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
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379847
- Sponsor's protocol ID
- 087-CL-080
- Status last verified
- Apr 2014
- First submitted
- 21 Sep 2006
- 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 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT00379847
- Acronym / sponsor ID
- 087-CL-080
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, hypervolemic, euvolemic, treatment outcomes, YM087
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 25 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: conivaptanLower dose |
| 2 | Experimental | Drug: conivaptanHigher dose |
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 less than or equal 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 |
|---|---|---|
| conivaptanAlso: Vaprisol, YM087IV | Drug | 1, 2 |
Primary outcome
Baseline-adjusted change in AUC for serum sodium
Time frame: 96 Hours
1 secondary outcome
Comparison of safety between patients in each study arm
Time frame: 96 Hours
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
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conivaptan in people with Hyponatremia, run by Cumberland Pharmaceuticals at 28 sites in 3 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 28 sites in Israel, South Africa, United States. 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?
Baseline-adjusted change in AUC for serum sodium (time frame: 96 Hours). 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.