DiabetesPhase 4NCT01349114
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
A Phase 4 study testing aliskiren 300 mg once daily in people with Diabetes and Pre-hypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diabetes, Pre-hypertension, Hypertension
- What is being tested?
- aliskiren 300 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- prehypertension or Stage 1 hypertension
Who cannot join
- Type 1 diabetes
- Stage 2 hypertension
- CKD
- recent MI, revascularization, CVA or TIA
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
Read the detailed description
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
- Conditions
- Diabetes, Pre-hypertension, Hypertension
- Being tested
- aliskiren 300 mg once daily, Placebo/sugar pill
- Keywords
- aliskiren, endothelial function, hypertension
- Medical subject headings
- Diabetes Mellitus, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskiren 300 mg once dailyDrug
Also called Tekturna
aliskiren 300 mg daily
Placebo/sugar pillDrug
Sugar pill/placebo
| Study group | Role | What they receive |
|---|---|---|
| aliskiren 300 mg once daily for 12 weeks | Active comparator | aliskiren 300 mg daily Receives: Drug: aliskiren 300 mg once daily |
| Sugar pill/ placebo | Placebo comparator | Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo Receives: Drug: Placebo/sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow-mediated Dilation
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
Measured: Baseline to 3 months
Secondary outcomes (1)
Mean Central Aortic Pressure at 3 Months
Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)
Measured: 3 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Sponsor requested termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, David Calhoun, University of Alabama at Birmingham
- Investigators
- David A Calhoun, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349114
- Sponsor's protocol ID
- F110124007
- Status last verified
- Apr 2017
- First submitted
- 4 May 2011
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01349114
- Acronym / sponsor ID
- F110124007
- Conditions
- Diabetes, Pre-hypertension, Hypertension
- Keywords
- aliskiren, endothelial function, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor requested termination.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
Detailed description
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aliskiren 300 mg once daily for 12 weeks | Active comparator | Drug: aliskiren 300 mg once dailyaliskiren 300 mg daily |
| Sugar pill/ placebo | Placebo comparator | Drug: Placebo/sugar pillPatients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- prehypertension or Stage 1 hypertension
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Stage 2 hypertension
- CKD
- recent MI, revascularization, CVA or TIA
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 |
|---|---|---|
| aliskiren 300 mg once dailyAlso: Tekturnaaliskiren 300 mg daily | Drug | aliskiren 300 mg once daily for 12 weeks |
| Placebo/sugar pillSugar pill/placebo | Drug | Sugar pill/ placebo |
Primary outcome
Change in Flow-mediated Dilation
Time frame: Baseline to 3 months
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
1 secondary outcome
Mean Central Aortic Pressure at 3 Months
Time frame: 3 months after start of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David A Calhoun, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aliskiren 300 mg once daily in people with Diabetes and Pre-hypertension, run by University of Alabama at Birmingham 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 May 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Flow-mediated Dilation (time frame: Baseline to 3 months). 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 11 May 2017.