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

June 12, 2012 updated by: VIVUS LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • MDS Pharma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Drug: Sildenafil citrate
2 sildenafil citrate 50 mg capsules
Placebo Comparator: Treatment C
placebo + glyceryl trinitrate
Drug: Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Drug: Placebo
2 placebo capsules for TA-1790 100 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemodynamic measurements
Time Frame: 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.
Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Investigators

  • Study Director: Craig Peterson, MS, VIVUS LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on TA-1790

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe