Blood PressurePhase 3NCT00874120
Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)
A Phase 3 study testing Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg in people with Blood Pressure and Human Experimentation, run by Bayer.
Trial summary
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Human Experimentation
- What is being tested?
- Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, male or female volunteers must be 18 years or older, with a Body Mass Index (BMI) between 19-30 inclusive [BMI = weight (kilograms)/height (meters squared)].
- Clinical laboratory tests (complete blood count, blood chemistries, urinalysis), Human Immunodeficiency Virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibody must be within normal limits or clinically acceptable to the Investigator/Sponsor.
- Drug screen for drugs and alcohol with a high potential for abuse must be negative at screening.
- Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures or participation.
- Subjects must agree not to take a monoamine oxidase inhibitor (MAOI) for two weeks (14 days) prior to study participation and for two weeks (14 days) after the end of their study participation.
- Subjects must have normal or clinically acceptable physical exam and Electrocardiogram (ECG) intervals (PR, QRS, QT and QTc) on 12-lead ECG (recorded at 25 millimeters/second [mm/s]).
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- Subjects must have a mean after 5 minute of rest sitting systolic/diastolic office blood pressure ≤ 138/88 millimeters of mercury (mmHg).
- Subjects with controlled diabetes prior to entry must have a mean sitting after 5 minute of rest systolic/diastolic office blood pressure ≤ 128/78 mmHg from non-dominated arm
- Females must have the urine or serum pregnancy test (Human Chorionic Gonadotropin) that is negative at Screening and Day 1 of Period 1.
- Female subjects of childbearing potential must be using medically acceptable birth control measures.
- Subjects must understand the dosing schedule.
- Subjects must be able to read and write in English.
Who cannot join
- Subjects must not have any significant medical condition which, in the judgment of the Investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include hyperthyroidism, hypothyroidism, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
- Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration.
- Subjects who have received an investigational drug within 30 days prior to study dosing.
- Subjects who are, appear to be, or are known, current or former drug addicts or alcoholics.
- Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody.
- Subjects who are positive for HIV antibodies.
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- Subjects who have a clinically significant history of food or drug allergy.
- Subjects who have a known allergy or intolerance to phenylephrine HCl.
- Females who are pregnant, nursing or unwilling to use/practice adequate contraception (hormonal, Intrauterine Device, barrier method, etc.).
- Subjects taking topical or oral decongestant products within 7 days of Visit 2.
- Subjects taking antihypertensive medication.
- Subjects taking monoamine oxidase inhibitors.
- Subjects taking tricyclic antidepressants (e.g. amitriptyline, nortriptyline, imipramine)
- Subjects taking antithyroid medication (e.g. propylthiouracil, methimazole, iodides).
About this study
Official title: Randomized, Placebo-Controlled, Double-Blind, Two-Way Crossover Study to Evaluate the Effects of Phenylephrine HCl Extended-Release Tablets 30 mg Compared to Placebo on Ambulatory Blood Pressure
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.
- Conditions
- Blood Pressure, Human Experimentation
- Being tested
- Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mgDrug
Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.
PlaceboDrug
Placebo taken twice daily (12 hours apart) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine HCl Extended-Release tablets 30 mg | Experimental | Phenylephrine HCl Extended Release tablets 30 mg Receives: Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).
Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.
Measured: 24 hours after final dose of each 7-day treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874120
- Sponsor's protocol ID
- 18121
- Other IDs
- CL2007-07, P07529
- Status last verified
- Feb 2015
- First submitted
- 1 Apr 2009
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Double-Blind, Two-Way Crossover Study to Evaluate the Effects of Phenylephrine HCl Extended-Release Tablets 30 mg Compared to Placebo on Ambulatory Blood Pressure
- ClinicalTrials.gov ID
- NCT00874120
- Acronym / sponsor ID
- 18121
- Conditions
- Blood Pressure, Human Experimentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine HCl Extended-Release tablets 30 mg | Experimental | Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mgPhenylephrine HCl Extended Release tablets 30 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy, male or female volunteers must be 18 years or older, with a Body Mass Index (BMI) between 19-30 inclusive [BMI = weight (kilograms)/height (meters squared)].
- Clinical laboratory tests (complete blood count, blood chemistries, urinalysis), Human Immunodeficiency Virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibody must be within normal limits or clinically acceptable to the Investigator/Sponsor.
- Drug screen for drugs and alcohol with a high potential for abuse must be negative at screening.
- Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures or participation.
- Subjects must agree not to take a monoamine oxidase inhibitor (MAOI) for two weeks (14 days) prior to study participation and for two weeks (14 days) after the end of their study participation.
Key exclusion criteria (14 listed)
- Subjects must not have any significant medical condition which, in the judgment of the Investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include hyperthyroidism, hypothyroidism, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
- Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration.
- Subjects who have received an investigational drug within 30 days prior to study dosing.
- Subjects who are, appear to be, or are known, current or former drug addicts or alcoholics.
- Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody.
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 Hydrochloride (HCl) Extended-Release tablets 30 mgPhenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days. | Drug | Phenylephrine HCl Extended-Release tablets 30 mg |
| PlaceboPlacebo taken twice daily (12 hours apart) for 7 days. | Drug | Placebo |
Primary outcome
Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).
Time frame: 24 hours after final dose of each 7-day treatment period.
Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg in people with Blood Pressure and Human Experimentation, run by Bayer.
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 12 inclusion and 14 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax). (time frame: 24 hours after final dose of each 7-day treatment period.). 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 11 Mar 2015.