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Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01616485
First received: June 7, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes

June 7, 2012
June 12, 2012
March 2004
May 2004   (final data collection date for primary outcome measure)
Change in hemodynamic measurements [ Time Frame: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose. ] [ Designated as safety issue: Yes ]
Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.
Same as current
Complete list of historical versions of study NCT01616485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo

The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: TA-1790
    2 TA-1790 100 mg capsules
  • Drug: Sildenafil citrate
    2 sildenafil citrate 50 mg capsules
  • Drug: Placebo
    2 placebo capsules for TA-1790 100 mg capsules
  • Drug: Nitrostat
    glyceryl trinitrate tablet, USP 0.4 mg
  • Experimental: Treatment A
    TA-1790 + glyceryl trinitrate
    Interventions:
    • Drug: TA-1790
    • Drug: Nitrostat
  • Active Comparator: Treatment B
    sildenafil citrate + glyceryl trinitrate
    Interventions:
    • Drug: Sildenafil citrate
    • Drug: Nitrostat
  • Placebo Comparator: Treatment C
    placebo + glyceryl trinitrate
    Interventions:
    • Drug: Placebo
    • Drug: Nitrostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
May 2004
May 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide written informed consent
  • Willing to comply with all study requirements and clinic schedules
  • Male between 30 to 60 years of age
  • Non-smoker
  • No history of alcohol abuse
  • Normal screening laboratory values

Exclusion Criteria:

  • Allergy or hypersensitive to PDE5 inhibitors
  • Evidence of clinically significant disease
  • Supine systolic/diastolic blood pressure level
  • History of cardiovascular disease
  • Previously participated in TA-1790 within the past 30 days
Male
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01616485
TA-04
Yes
VIVUS, Inc.
VIVUS, Inc.
Not Provided
Study Director: Craig Peterson, MS VIVUS, Inc.
VIVUS, Inc.
June 2012

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