Heart DiseasesNCT00415428
A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.
An observational study of Heart Diseases and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Patient adherence to national educational guidelines.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,776 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Sep 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic patients
Who may be able to join
- Subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. The following subjects qualify for inclusion in the study:
- Subjects for whom measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, blood pressure (BP) and glycosylated hemoglobin (HbA1c) was planned independently of this observational study and for whom baseline values were or became available.
- Subjects with known CVD diagnosed > or = 6 months before inclusion
- Previous myocardial infarction
- Ischemic heart disease (stable and unstable angina pectoris)
- Ischemic apoplexy
Show all 10Show fewer
- Peripheral arterial disease
- And/Or
- Subjects with T2D diagnosed > or = 6 months before inclusion
- At least 50% of the subjects had to have CVD as the primary diagnosis. It was allowed for a secondary diagnosis to be <6 months before inclusion.
Who cannot join
- Subjects presenting with any of the following were not to be included in the study:
- Life expectancy of < or = 2 years
- Unable/unwilling to understand/follow instructions
- Taking part in a clinical study involving an investigational drug
- Followed by a specialist for their CVD and/or T2D at the time of inclusion in the study
About this study
Official title: Patient And Physician Alliance -Guideline Education Treatment Optimization
The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.
- Conditions
- Heart Diseases, Diabetes Mellitus, Type 2
- Being tested
- Patient adherence to national educational guidelines.
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient adherence to national educational guidelines.Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 1. | Not described Receives: Behavioral: Patient adherence to national educational guidelines. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,776 participants (actual)
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
- NCT00415428
- Sponsor's protocol ID
- A2581154
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2006
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient And Physician Alliance -Guideline Education Treatment Optimization
- ClinicalTrials.gov ID
- NCT00415428
- Acronym / sponsor ID
- A2581154
- Conditions
- Heart Diseases, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Dec 2006 (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 overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | – | Behavioral: Patient adherence to national educational guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic patients
Key inclusion criteria (10 listed)
- Subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. The following subjects qualify for inclusion in the study:
- Subjects for whom measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, blood pressure (BP) and glycosylated hemoglobin (HbA1c) was planned independently of this observational study and for whom baseline values were or became available.
- Subjects with known CVD diagnosed > or = 6 months before inclusion
- Previous myocardial infarction
- Ischemic heart disease (stable and unstable angina pectoris)
Key exclusion criteria (5 listed)
- Subjects presenting with any of the following were not to be included in the study:
- Life expectancy of < or = 2 years
- Unable/unwilling to understand/follow instructions
- Taking part in a clinical study involving an investigational drug
- Followed by a specialist for their CVD and/or T2D at the time of inclusion in the study
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 |
|---|---|---|
| Patient adherence to national educational guidelines. | Behavioural | 1. |
Primary outcome
Not reported in the source record.
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 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Heart Diseases
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
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
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 10 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 18 Feb 2021.