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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
  Purpose

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 Intervention Phase
Erectile Dysfunction
 Drug: TA-1790
Drug: Sildenafil citrate
Drug: Placebo
Drug: Nitrostat
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 106
Study Start Date: March 2004
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616485

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

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01616485     History of Changes
Other Study ID Numbers: TA-04
Study First Received: June 7, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Citric Acid
Sildenafil
Nitroglycerin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013