- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874120
Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)
February 20, 2015 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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]).
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo taken twice daily (12 hours apart) for 7 days.
|
Experimental: Phenylephrine HCl Extended-Release tablets 30 mg
Phenylephrine HCl Extended Release tablets 30 mg
|
Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours after final dose of each 7-day treatment period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
April 1, 2009
First Submitted That Met QC Criteria
April 1, 2009
First Posted (Estimate)
April 2, 2009
Study Record Updates
Last Update Posted (Estimate)
March 11, 2015
Last Update Submitted That Met QC Criteria
February 20, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 18121
- CL2007-07
- P07529 (Other Identifier: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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