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

• Sponsor: VIVUS LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01616485
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 52.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: TA-1790; Drug: Sildenafil citrate; Drug: Placebo; Drug: Nitrostat	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2004
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A TA-1790 + glyceryl trinitrate	Drug: TA-1790; 2 TA-1790 100 mg capsules; Drug: Nitrostat; glyceryl trinitrate tablet, USP 0.4 mg
Active Comparator: Treatment B sildenafil citrate + glyceryl trinitrate	Drug: Sildenafil citrate; 2 sildenafil citrate 50 mg capsules; Drug: Nitrostat; glyceryl trinitrate tablet, USP 0.4 mg
Placebo Comparator: Treatment C placebo + glyceryl trinitrate	Drug: Placebo; 2 placebo capsules for TA-1790 100 mg capsules; Drug: Nitrostat; glyceryl trinitrate tablet, USP 0.4 mg

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MDS Pharma Services	Phoenix	Arizona	United States

Sponsors and Collaborators

• VIVUS LLC

Investigators

• Study Director: Craig Peterson, MS, VIVUS LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VIVUS LLC
• ClinicalTrials.gov Identifier: NCT01616485
• Other Study ID Numbers: TA-04
• First Posted: Jun 11, 2012
• Last Update Posted: Jun 14, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate; Nitroglycerin

Study Results

No Results Posted as of Jun 14, 2012