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

Vivus

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: Sildenafil citrate; Drug: TA-1790; Drug: Nitrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01616485

TA-04

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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106 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Description:

TA-1790 + glyceryl trinitrate

Treatment:

Drug: Nitrostat

Drug: TA-1790

Treatment B

Active Comparator group

Description:

sildenafil citrate + glyceryl trinitrate

Treatment:

Drug: Nitrostat

Drug: Sildenafil citrate

Treatment C

Placebo Comparator group

Description:

placebo + glyceryl trinitrate

Treatment:

Drug: Nitrostat

Drug: Placebo