Heart RatePhase 1/2NCT01026961
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
A Phase 1/2 study testing Phenylephrine HCL and Phenylephrine HCL/Acetaminophen/Dimethindene Maleate in people with Heart Rate and Blood Pressure, run by Novartis at 1 site in Brazil.
Trial summary
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Heart Rate, Blood Pressure, Arrhythmias
- What is being tested?
- Phenylephrine HCL and Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Nov 2010
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy volunteers between 18 and 50 years;
- Clinical examination without abnormal findings
- Ability to understand the nature and purpose of the study, including the risks and adverse effects
Who cannot join
- Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
- History of serious adverse reactions or hypersensitivity any drug
- Hypersensitivity to the drug study drugs or chemically related compounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
- Conditions
- Heart Rate, Blood Pressure, Arrhythmias
- Being tested
- Phenylephrine HCL, Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
- Keywords
- Safety, heart rate, systolic and diastolic blood pressure, arrhythmias
- Medical subject headings
- Arrhythmias, Cardiac, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine HCLDrug
Phenylephrine HCL 10mg
Phenylephrine HCL/Acetaminophen/Dimethindene MaleateDrug
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine HCL/Acetaminophen/Dimethindene Maleate | Experimental | Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Receives: Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate |
| Phenylephrine hydrochloride | Active comparator | Phenylephrine hydrochloride 10mg Receives: Drug: Phenylephrine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
Measured: 15 days
Secondary outcomes (2)
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
Measured: 15 days
To report and evaluate adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startSep 2010
- Primary completionNov 2010 (estimated)
Why it stopped: Study is no longer required by Brazil health authority.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Biociências S.A, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026961
- Sponsor's protocol ID
- 381-A-101
- Status last verified
- Mar 2016
- First submitted
- 4 Dec 2009
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01026961
- Acronym / sponsor ID
- 381-A-101
- Conditions
- Heart Rate, Blood Pressure, Arrhythmias
- Keywords
- Safety, heart rate, systolic and diastolic blood pressure, arrhythmias
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is no longer required by Brazil health authority.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (estimated)
- First posted
- 7 Dec 2009 (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 evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine HCL/Acetaminophen/Dimethindene Maleate | Experimental | Drug: Phenylephrine HCL/Acetaminophen/Dimethindene MaleatePhenylephrine HCL/Acetaminophen/Dimethindene Maleate |
| Phenylephrine hydrochloride | Active comparator | Drug: Phenylephrine HCLPhenylephrine hydrochloride 10mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers between 18 and 50 years;
- Clinical examination without abnormal findings
- Ability to understand the nature and purpose of the study, including the risks and adverse effects
Key exclusion criteria (3 listed)
- Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
- History of serious adverse reactions or hypersensitivity any drug
- Hypersensitivity to the drug study drugs or chemically related compounds
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 |
|---|---|---|
| Phenylephrine HCLPhenylephrine HCL 10mg | Drug | Phenylephrine hydrochloride |
| Phenylephrine HCL/Acetaminophen/Dimethindene MaleatePhenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg | Drug | Phenylephrine HCL/Acetaminophen/Dimethindene Maleate |
Primary outcome
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
Time frame: 15 days
2 secondary outcomes
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
Time frame: 15 days
To report and evaluate adverse events
Time frame: 15 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Related InfoLink provided by the sponsor.
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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.
Novartis Biociências S.A study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phenylephrine HCL and Phenylephrine HCL/Acetaminophen/Dimethindene Maleate in people with Heart Rate and Blood Pressure, run by Novartis at 1 site in Brazil.
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 3 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: withdrawn, as of the sponsor's last update on 3 Mar 2016. 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 Brazil. 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs (time frame: 15 days). 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 3 Mar 2016.