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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.


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


Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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