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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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TA-1790

Sildenafil citrate

Placebo

Nitrostat

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

MDS Pharma Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

TA-1790 + glyceryl trinitrate

sildenafil citrate + glyceryl trinitrate

placebo + glyceryl trinitrate

Outcomes

Primary Outcome Measures

Change in hemodynamic measurements

Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

Secondary Outcome Measures

Full Information

NCT ID

NCT01616485

First Posted

June 7, 2012

Last Updated

June 12, 2012

Sponsor

VIVUS LLC

1. Study Identification

Unique Protocol Identification Number

NCT01616485

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VIVUS LLC

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Description

TA-1790 + glyceryl trinitrate

Arm Title

Treatment B

Arm Type

Active Comparator

Arm Description

sildenafil citrate + glyceryl trinitrate

Arm Title

Treatment C

Arm Type

Placebo Comparator

Arm Description

placebo + glyceryl trinitrate

Intervention Type

Drug

Intervention Name(s)

TA-1790

Intervention Description

2 TA-1790 100 mg capsules

Intervention Type

Drug

Intervention Name(s)

Sildenafil citrate

Intervention Description

2 sildenafil citrate 50 mg capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 placebo capsules for TA-1790 100 mg capsules

Intervention Type

Drug

Intervention Name(s)

Nitrostat

Intervention Description

glyceryl trinitrate tablet, USP 0.4 mg

Primary Outcome Measure Information:

Title

Change in hemodynamic measurements

Description

Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.

Time Frame

Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Peterson, MS

Organizational Affiliation

VIVUS LLC

Official's Role

Study Director

Facility Information:

Facility Name

MDS Pharma Services

City

Phoenix

State/Province

Arizona

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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