HypocalcemiaPhase 2NCT00053378
A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
A Phase 2 study testing paricalcitol injection (Zemplar), Effects on calcium regulation and Administration of elemental Ca during hypocalcemic ICU pts. in people with Hypocalcemia, run by Abbott at 9 sites in United States.
Trial summary
A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- paricalcitol injection (Zemplar), Effects on calcium regulation and Administration of elemental Ca during hypocalcemic ICU pts.
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2002to not given
- Phase
- Phase 2
- 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
- ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.
Who cannot join
- Serum creatinine greater than 2.5 mg/dL
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
University of Chicago
Chicago, Illinois, 60637
Denver Health Medical Center
Denver, Colorado, 80204
Heart Care Associates
Hopewell, Virginia, 23860
Outcomes Research Institute
Hudson, Florida, 34667
Central Baptist Hospital Clinical Research Center
Lexington, Kentucky, 40503
Merced Heart Association
Merced, California, 95340
Florida Hospital
Orlando, Florida, 32803
Strong Memorial Hospital
Rochester, New York, 14642
About this study
Official title: A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients
- Conditions
- Hypocalcemia
- Being tested
- paricalcitol injection (Zemplar), Effects on calcium regulation, Administration of elemental Ca during hypocalcemic ICU pts.
- Keywords
- hypocalcemia, ionized calcium, intensive care
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitol injection (Zemplar)Drug
Effects on calcium regulationBehavioural
Administration of elemental Ca during hypocalcemic ICU pts.Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypocalcemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joel Z Melnick, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053378
- Sponsor's protocol ID
- M01-395
- Status last verified
- Jul 2006
- First submitted
- 27 Jan 2003
- Last updated
- 2 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects
- ClinicalTrials.gov ID
- NCT00053378
- Acronym / sponsor ID
- M01-395
- Conditions
- Hypocalcemia
- Keywords
- hypocalcemia, ionized calcium, intensive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- First posted
- 28 Jan 2003 (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.
A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 (1 listed)
- ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.
Key exclusion criteria (1 listed)
- Serum creatinine greater than 2.5 mg/dL
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 |
|---|---|---|
| paricalcitol injection (Zemplar) | Drug | – |
| Effects on calcium regulation | Behavioural | – |
| Administration of elemental Ca during hypocalcemic ICU pts. | Behavioural | – |
Primary outcome
The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.
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 Aug 2006.
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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.
Joel Z Melnick, M.D. study director
Abbott
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paricalcitol injection (Zemplar), Effects on calcium regulation and Administration of elemental Ca during hypocalcemic ICU pts. in people with Hypocalcemia, run by Abbott at 9 sites in United States.
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 1 inclusion and 1 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 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels.. 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 Aug 2006.