DiabetesNCT01393860
Real-world Aliskiren Use in Diabetic Patients
An observational study of Diabetes and Hypertension, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2011
- 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: Diabetic patients with hypertension who were initiated on aliskiren
Who may be able to join
- Type 2 diabetes
- Patients ages 18 yeras and older
- Hypertension Diagnosis
- Currently on at least 1 hypertensive medication
- At least 2 lab measure before and after aliskiren initiation
Who cannot join
- Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
- Pregnancy
- Development of secondary renal disease unrelated to diabetes (such as nephritis)
- Terminal illness
- AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North
Baltimore, Maryland, MD 21204
About this study
Official title: Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?
The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes, aliskiren, hypertension, renal impairment
- Medical subject headings
- Diabetes Mellitus, Hypertension, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Diabetic nephropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Change in blood pressure
Measured: baseline and 1 year
Secondary outcomes (3)
Measure: Change in urine microalbumin
Measured: baseline and 1 year
Measure: Change in creatinine
Measured: baseline and 1 year
Measure: Change in potassium levels
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Phamaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393860
- Sponsor's protocol ID
- HEORUS0081
- Status last verified
- Jul 2011
- First submitted
- 11 Jul 2011
- Last updated
- 14 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?
- ClinicalTrials.gov ID
- NCT01393860
- Acronym / sponsor ID
- HEORUS0081
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes, aliskiren, hypertension, renal impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 13 Jul 2011 (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 this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | – | –Diabetic nephropathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with hypertension who were initiated on aliskiren
Key inclusion criteria (5 listed)
- Type 2 diabetes
- Patients ages 18 yeras and older
- Hypertension Diagnosis
- Currently on at least 1 hypertensive medication
- At least 2 lab measure before and after aliskiren initiation
Key exclusion criteria (5 listed)
- Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren
- Pregnancy
- Development of secondary renal disease unrelated to diabetes (such as nephritis)
- Terminal illness
- AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure: Change in blood pressure
Time frame: baseline and 1 year
3 secondary outcomes
Measure: Change in urine microalbumin
Time frame: baseline and 1 year
Measure: Change in creatinine
Time frame: baseline and 1 year
Measure: Change in potassium levels
Time frame: baseline and 1 year
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 Jul 2011.
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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.
Novartis Pharmaceuticals study director
Novartis Phamaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hypertension, run by Novartis 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 5 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 Jul 2011. 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. 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.
What does the primary outcome measure?
Measure: Change in blood pressure (time frame: baseline and 1 year). 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 Jul 2011.