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
- 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
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Phoenix, Arizona, United States