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Trial record 1 of 1 for:    NCT00645034
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A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin

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ClinicalTrials.gov Identifier: NCT00645034
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 10, 2017
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 20, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Pharmacodynamic parameters of blood pressure and pulse rate [ Time Frame: immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00645034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
  • Blood samples for doxazosin pharmacokinetic parameters [ Time Frame: time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose ]
  • Safety and toleration of simultaneously co-administering sildenafil and doxazosin. [ Time Frame: continuous ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effects on Blood Pressure and Pulse Rate of a Single 100mg Dose of Sildenafil in Patients With Benign Prostatic Hyperplasia Who Are Being Treated With Doxazosin
Official Title  ICMJE A Double-blind, Placebo-controlled, Randomized, 2-way Crossover Study to Investigate the Hemodynamic Effects of a Single Dose of Sildenafil (100mg) in Subjects With Benign Prostatic Hyperplasia Being Treated With Doxazosin
Brief Summary To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH). To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg, and to investigate the safety and toleration of sildenafil 100 mg when co-administered with doxazosin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: placebo
    placebo by mouth as a single dose
  • Drug: sildenafil
    sildenafil 100 mg by mouth as a single dose
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who weighed between 132 and 220 lb (60 and 100 kg) with benign prostatic hyperplasia (BPH)
  • a total PSA (prostate specific antigen) measurement of less than or equal to 10 µg/L within the 12 months prior to screening, were currently on doxazosin treatment for BPH, had been treated with doxazosin for a minimum of 2 months prior to first dose of study medication, and had received a minimum of 4 mg doxazosin once daily (from doxazosin supplied for this study) for 2 weeks prior to the first dose of study medication.

Exclusion Criteria:

  • subjects with a recent history (i.e. within 6 months prior to screening) of stroke or myocardial infarction
  • subjects with severe cardiovascular disorders such as unstable angina or severe congestive heart failure
  • subjects with known hereditary degenerative retinal disorders, such as retinitis pigmentosa
  • subjects with a supine systolic/diastolic blood pressure of >170/100 mmHg or <100/60 mmHg either at screening or at the pre-dose measurements
  • subjects receiving any other antihypertensive therapy other than doxazosin in the 3 weeks prior to the first dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645034
Other Study ID Numbers  ICMJE A1481163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP