AnxietyPhase 3NCT00151450
Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
A Phase 3 study testing Pregabalin and Venlafaxine XR in people with Anxiety, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 45 sites in 8 countries.
Trial summary
The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Pregabalin and Venlafaxine XR
- How many people
- 390 participants
- Where
- 45 sitesin 8 countries
- Study dates
- Mar 2005to Nov 2006
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients with diagnosis of generalized anxiety disorder.
Who cannot join
- Any serious or uncontrolled medical condition.
- Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.
Trial locations and contacts
45 sites in 8 countries.
45 sites in 8 countries
France11 sites
Pfizer Investigational Site
Angoulême
Pfizer Investigational Site
Arcachon
Pfizer Investigational Site
Bully-les-Mines
Pfizer Investigational Site
Cherbourg
Pfizer Investigational Site
Élancourt
Pfizer Investigational Site
Orvault
Pfizer Investigational Site
Rennes
Pfizer Investigational Site
Saint-André-de-Cubzac
Pfizer Investigational Site
Savigny-sur-Orge
Pfizer Investigational Site
Strasbourg
Pfizer Investigational Site
Versailles
Spain8 sites
Pfizer Investigational Site
Alcalá de Henares, Madrid
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Gandia, Valencia
Pfizer Investigational Site
Langreo, Principality of Asturias
Pfizer Investigational Site
Madrid
Pfizer Investigational Site
Salamanca
Pfizer Investigational Site
Vic, Barcelona
Pfizer Investigational Site
Zamora
Sweden7 sites
Pfizer Investigational Site
Gothenburg
Pfizer Investigational Site
Linköping
Pfizer Investigational Site
Lund
Pfizer Investigational Site
Malmö
Pfizer Investigational Site
Stockholm
Pfizer Investigational Site
Sundsvall
Pfizer Investigational Site
Trollhättan
Netherlands6 sites
Pfizer Investigational Site
Hoogvliet
Pfizer Investigational Site
Huizen
Pfizer Investigational Site
Losser
Pfizer Investigational Site
Musselkanaal
Pfizer Investigational Site
Oude Pekela
Pfizer Investigational Site
Wildervank, Provincie Groningen
Canada5 sites
Pfizer Investigational Site
Gatineau, Quebec
Pfizer Investigational Site
Hamilton, Ontario
Pfizer Investigational Site
Kelowna, British Columbia
Pfizer Investigational Site
Ottawa, Ontario
Pfizer Investigational Site
Saint-Jean-sur-Richelieu, Quebec
Italy4 sites
Pfizer Investigational Site
Catania
Pfizer Investigational Site
Città di Castello, Perugia
Pfizer Investigational Site
Sassari
Pfizer Investigational Site
Vicenza, Bassano DEL Grappa
Belgium3 sites
Pfizer Investigational Site
De Pinte
Pfizer Investigational Site
Ghent
Pfizer Investigational Site
Waregem
About this study
Official title: An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients
The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.
- Conditions
- Anxiety
- Being tested
- Pregabalin, Venlafaxine XR
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Venlafaxine XRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMar 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 390 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151450
- Sponsor's protocol ID
- A0081012
- Status last verified
- Mar 2008
- First submitted
- 7 Sep 2005
- Last updated
- 22 Jan 2021
- Results posted
- No
Publications
Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96. doi: 10.1097/yic.0b013e32831d7980.
PubMed 21456104
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients
- ClinicalTrials.gov ID
- NCT00151450
- Acronym / sponsor ID
- A0081012
- Conditions
- Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 9 Sep 2005 (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 purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female outpatients with diagnosis of generalized anxiety disorder.
Key exclusion criteria (2 listed)
- Any serious or uncontrolled medical condition.
- Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.
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 |
|---|---|---|
| Pregabalin | Drug | – |
| Venlafaxine XR | Drug | – |
Primary outcome
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
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 22 Jan 2021.
- Derived from this study: PubMed 21456104Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96. doi: 10.1097/yic.0b013e32831d7980.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Venlafaxine XR in people with Anxiety, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 45 sites in 8 countries.
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 1 inclusion and 2 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in France, Spain, Sweden, Netherlands, Canada and 3 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151450, which also lists 1 linked publication.
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 22 Jan 2021.