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
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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
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
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
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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