Erectile DysfunctionPhase 1NCT01616485
Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
A Phase 1 study testing TA-1790, Sildenafil citrate and Nitrostat in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- TA-1790, Sildenafil citrate and Nitrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to May 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction
- Being tested
- TA-1790, Sildenafil citrate, Placebo, Nitrostat
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-1790Drug
2 TA-1790 100 mg capsules
Sildenafil citrateDrug
2 sildenafil citrate 50 mg capsules
PlaceboDrug
2 placebo capsules for TA-1790 100 mg capsules
NitrostatDrug
glyceryl trinitrate tablet, USP 0.4 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | TA-1790 + glyceryl trinitrate Receives: Drug: TA-1790; Drug: Nitrostat |
| Treatment B | Active comparator | sildenafil citrate + glyceryl trinitrate Receives: Drug: Sildenafil citrate; Drug: Nitrostat |
| Treatment C | Placebo comparator | placebo + glyceryl trinitrate Receives: Drug: Placebo; Drug: Nitrostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemodynamic measurements
Change in hemodynamic measurements consisted of blood pressure and pulse rate measurements.
Measured: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startMar 2004
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Peterson, MS, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616485
- Sponsor's protocol ID
- TA-04
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Crossover Evaluation of the Hemodynamic Response to Sublingual Glyceryl Trinitrate in Patients Receiving TA-1790, Sildenafil, and Placebo
- ClinicalTrials.gov ID
- NCT01616485
- Acronym / sponsor ID
- TA-04
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: TA-1790, Drug: NitrostatTA-1790 + glyceryl trinitrate |
| Treatment B | Active comparator | Drug: Sildenafil citrate, Drug: Nitrostatsildenafil citrate + glyceryl trinitrate |
| Treatment C | Placebo comparator | Drug: Placebo, Drug: Nitrostatplacebo + glyceryl trinitrate |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-17902 TA-1790 100 mg capsules | Drug | Treatment A |
| Sildenafil citrate2 sildenafil citrate 50 mg capsules | Drug | Treatment B |
| Placebo2 placebo capsules for TA-1790 100 mg capsules | Drug | Treatment C |
| Nitrostatglyceryl trinitrate tablet, USP 0.4 mg | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Peterson, MS study director
VIVUS LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TA-1790, Sildenafil citrate and Nitrostat in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemodynamic measurements (time frame: Pre-dose, 5 min interval for first 45 minutes. 60, 90, and 120 minutes post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.