A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- VIVUS LLC
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Change in hemodynamic measurements
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Treatment A
TA-1790 + glyceryl trinitrate
Intervention: TA-1790 (Drug)
Treatment A
TA-1790 + glyceryl trinitrate
Intervention: Nitrostat (Drug)
Treatment B
sildenafil citrate + glyceryl trinitrate
Intervention: Sildenafil citrate (Drug)
Treatment B
sildenafil citrate + glyceryl trinitrate
Intervention: Nitrostat (Drug)
Treatment C
placebo + glyceryl trinitrate
Intervention: Placebo (Drug)
Treatment C
placebo + glyceryl trinitrate
Intervention: Nitrostat (Drug)
Outcomes
Primary Outcomes
Change in hemodynamic measurements
Time Frame: 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 Outcomes
No secondary outcomes reported