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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: TA-1790; Drug: Sildenafil citrate; Drug: Placebo; Drug: Nitrostat

• Registration Number: NCT01616485
• Lead Sponsor: VIVUS LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	TA-1790	TA-1790 + glyceryl trinitrate
Treatment A	Nitrostat	TA-1790 + glyceryl trinitrate
Treatment B	Sildenafil citrate	sildenafil citrate + glyceryl trinitrate
Treatment C	Placebo	placebo + glyceryl trinitrate
Treatment B	Nitrostat	sildenafil citrate + glyceryl trinitrate
Treatment C	Nitrostat	placebo + glyceryl trinitrate

Primary Outcome Measures

Name	Time	Method
Change in hemodynamic measurements	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.

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Phoenix, Arizona, United States