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

Erectile Dysfunction Clinical Trial

Official title:

A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616485
• Other study ID #: TA-04
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2012
• Last updated: June 12, 2012
• Start date: March 2004
• Est. completion date: May 2004

Study information

• Verified date: June 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• TA-1790
2 TA-1790 100 mg capsules
• Sildenafil citrate
2 sildenafil citrate 50 mg capsules
• Placebo
2 placebo capsules for TA-1790 100 mg capsules
• Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg

Locations

Country	Name	City	State
United States	MDS Pharma Services	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemodynamic measurements	Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.	Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.	Yes