Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01616485
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: TA-1790 Drug: Sildenafil citrate Drug: Placebo Drug: Nitrostat Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo
Study Start Date : March 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment A
TA-1790 + glyceryl trinitrate
 Drug: TA-1790
2 TA-1790 100 mg capsules

Drug: Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Active Comparator: Treatment B
sildenafil citrate + glyceryl trinitrate
 Drug: Sildenafil citrate
2 sildenafil citrate 50 mg capsules

Drug: Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Placebo Comparator: Treatment C
placebo + glyceryl trinitrate
 Drug: Placebo
2 placebo capsules for TA-1790 100 mg capsules

Drug: Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in hemodynamic measurements [ Time Frame: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose. ]
    Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01616485


Locations
Layout table for location information
United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Layout table for investigator information
Study Director: Craig Peterson, MS VIVUS, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01616485     History of Changes
Other Study ID Numbers: TA-04
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Nitroglycerin
Citric Acid
Sodium Citrate
Anticoagulants
 Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents