HealthyPhase 1NCT00310596
Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
A Phase 1 study testing Gadopentetate dimeglumine (Magnevist, BAY86-4882) and Moxifloxacin (BAY12-8039) in people with Healthy, run by Bayer at 1 site in United States.
Trial summary
The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Gadopentetate dimeglumine (Magnevist, BAY86-4882) and Moxifloxacin (BAY12-8039)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Mar 2004
- Phase
- Phase 1
- 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
- Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
- Non-smoker
Who cannot join
- History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control
The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).
Read the detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
- Conditions
- Healthy
- Being tested
- Gadopentetate dimeglumine (Magnevist, BAY86-4882), Moxifloxacin (BAY12-8039), Placebo
- Keywords
- ECG safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadopentetate dimeglumine (Magnevist, BAY86-4882)Drug
0,1mmol/kg at 10 mL/15 sec
Gadopentetate dimeglumine (Magnevist, BAY86-4882)Drug
same dose as arm 1 at bolus rate (2mL/sec)
Gadopentetate dimeglumine (Magnevist, BAY86-4882)Drug
0,3mmol/kg at 10 mL/15 sec
Gadopentetate dimeglumine (Magnevist, BAY86-4882)Drug
same dose as arm 3 at bolus rate (2mL/sec)
Moxifloxacin (BAY12-8039)Drug
400 mg at 0,07 mL/sec over 60 min
PlaceboDrug
0,9% saline at 0,6mL/kg at bolus rate
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 2 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 3 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 4 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 5 | Active comparator | Not described Receives: Drug: Moxifloxacin (BAY12-8039) |
| Arm 6 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study variable was heart-rate corrected QT (QTc) interval
Measured: Within 15 min postinjection
Secondary outcomes (2)
Adverse event monitoring, laboratory evaluations
Measured: 24 hrs postinjection
ECG variables and overall interpretation
Measured: 24 hrs postinjection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startJan 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BayerThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310596
- Sponsor's protocol ID
- 91024
- Other IDs
- 305340
- Status last verified
- Dec 2014
- First submitted
- 31 Mar 2006
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control
- ClinicalTrials.gov ID
- NCT00310596
- Acronym / sponsor ID
- 91024
- Conditions
- Healthy
- Keywords
- ECG safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Mar 2004 (actual)
- First posted
- 4 Apr 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.
The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 2 | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 3 | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 4 | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Arm 5 | Active comparator | Drug: Moxifloxacin (BAY12-8039) |
| Arm 6 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
- Non-smoker
Key exclusion criteria (1 listed)
- History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin
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 |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882)0,1mmol/kg at 10 mL/15 sec | Drug | Arm 1 |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882)same dose as arm 1 at bolus rate (2mL/sec) | Drug | Arm 2 |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882)0,3mmol/kg at 10 mL/15 sec | Drug | Arm 3 |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882)same dose as arm 3 at bolus rate (2mL/sec) | Drug | Arm 4 |
| Moxifloxacin (BAY12-8039)400 mg at 0,07 mL/sec over 60 min | Drug | Arm 5 |
| Placebo0,9% saline at 0,6mL/kg at bolus rate | Drug | Arm 6 |
Primary outcome
The primary study variable was heart-rate corrected QT (QTc) interval
Time frame: Within 15 min postinjection
2 secondary outcomes
Adverse event monitoring, laboratory evaluations
Time frame: 24 hrs postinjection
ECG variables and overall interpretation
Time frame: 24 hrs postinjection
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 30 Dec 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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gadopentetate dimeglumine (Magnevist, BAY86-4882) and Moxifloxacin (BAY12-8039) in people with Healthy, run by Bayer at 1 site 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 2 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 study variable was heart-rate corrected QT (QTc) interval (time frame: Within 15 min postinjection). 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 30 Dec 2014.