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Completed

NCT Number: NCT01616485

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TA-1790

Drug

2 TA-1790 100 mg capsules

sildenafil citrate

Drug

2 sildenafil citrate 50 mg capsules

Placebo

Drug

2 placebo capsules for TA-1790 100 mg capsules

Nitrostat

Drug

glyceryl trinitrate tablet, USP 0.4 mg

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study title

A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 11, 2012
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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