Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
NCT ID: NCT01616485
Last Updated: 2012-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
106 participants
INTERVENTIONAL
2004-03-31
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment A
TA-1790 + glyceryl trinitrate
TA-1790
2 TA-1790 100 mg capsules
Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Treatment B
sildenafil citrate + glyceryl trinitrate
Sildenafil citrate
2 sildenafil citrate 50 mg capsules
Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Treatment C
placebo + glyceryl trinitrate
Placebo
2 placebo capsules for TA-1790 100 mg capsules
Nitrostat
glyceryl trinitrate tablet, USP 0.4 mg
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
MALE
Yes
Sponsors
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VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Peterson, MS
Role: STUDY_DIRECTOR
VIVUS LLC
Locations
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MDS Pharma Services
Phoenix, Arizona, United States
Countries
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Other Identifiers
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TA-04
Identifier Type: -
Identifier Source: org_study_id
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