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

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 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
Primary Completion Date : May 2004
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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.

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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): NCT01616485

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States
Sponsors and Collaborators
Study Director: Craig Peterson, MS VIVUS, Inc.

Responsible Party: VIVUS, Inc. 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:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Citric Acid
Sildenafil Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents