Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
Information source: VIVUS, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: TA-1790 (Drug); Sildenafil citrate (Drug); Placebo (Drug); Nitrostat (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: VIVUS, Inc. Official(s) and/or principal investigator(s): Craig Peterson, MS, Study Director, Affiliation: VIVUS, Inc.
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.
Clinical Details
Official title: A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change in hemodynamic measurements
Eligibility
Minimum age: 30 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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 and Contacts
MDS Pharma Services, Phoenix, Arizona, United States
Additional Information
Starting date: March 2004
Last updated: June 12, 2012
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