Trial | NCT01616485  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    106
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.
Study Started
Mar 31
2004
Primary Completion
May 31
2004
Study Completion
May 31
2004
Last Update
Jun 14
2012
Estimate

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

Treatment A Experimental

TA-1790 + glyceryl trinitrate

Treatment B Active Comparator

sildenafil citrate + glyceryl trinitrate

Treatment C Placebo Comparator

placebo + glyceryl trinitrate

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
No Results Posted