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Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00874120
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 5, 2010
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Human Experimentation Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : December 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phenylephrine HCl Extended-Release tablets 30 mg
Phenylephrine HCl Extended Release tablets 30 mg
Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg
Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo taken twice daily (12 hours apart) for 7 days.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00874120    
Other Study ID Numbers: 18121
CL2007-07
P07529 ( Other Identifier: Merck )
First Posted: April 2, 2009    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: March 11, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents