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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00874120
First received: April 1, 2009
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 116
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00874120     History of Changes
Other Study ID Numbers: P07529, CL2007-07
Study First Received: April 1, 2009
Results First Received: June 2, 2010
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Oxymetazoline
Phenylephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014