Trial record 1 of 1 for:    "NCT01026961"
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Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01026961
Recruitment Status : Withdrawn (Study is no longer required by Brazil health authority.)
First Posted : December 7, 2009
Last Update Posted : March 3, 2016
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Rate Blood Pressure Arrhythmias Drug: Phenylephrine HCL Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : September 2010
Estimated Primary Completion Date : November 2010

Arm Intervention/treatment
Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg

Active Comparator: Phenylephrine hydrochloride
Phenylephrine hydrochloride 10mg
Drug: Phenylephrine HCL
Phenylephrine HCL 10mg

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing [ Time Frame: 15 days ]
  2. To report and evaluate adverse events [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01026961

Scentryphar Pesquisa Clinica Ltda.
Campinas, São Paulo, Brazil
Sponsors and Collaborators
Study Director: Novartis Biociências S.A Novartis

Additional Information:
Responsible Party: External Affairs, Novartis Biociências S.A Identifier: NCT01026961     History of Changes
Other Study ID Numbers: 381-A-101
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Novartis:
heart rate
systolic and diastolic blood pressure

Additional relevant MeSH terms:
Maleic acid
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cardiotonic Agents
Autonomic Agents
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
Enzyme Inhibitors
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists