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

VIVUS LLC106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Erectile Dysfunction

Interventions

TA-1790DRUG

2 TA-1790 100 mg capsules

Sildenafil citrateDRUG

2 sildenafil citrate 50 mg capsules

PlaceboDRUG

2 placebo capsules for TA-1790 100 mg capsules

Nitrostat

Eligibility

Sex: MALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MDS Pharma Services

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in hemodynamic measurements

Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

Time frame: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.

Data from ClinicalTrials.gov

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