HypertensionPhase 4NCT01038895
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
A Phase 4 study testing Ramipril and Experimental in people with Hypertension and Type 2 Diabetes, run by University of Pavia at 1 site in Italy.
Trial summary
The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes
- What is being tested?
- Ramipril and Experimental
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- blood pressure > 130/80 <180/105 mmHg at the end of the wash-out
- type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
- microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)
Who cannot join
- Pregnancy, lactation or women of childbearing age
- Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
- History of hypertensive encephalopathy or cerebrovascular accident within 6 months
- Secondary hypertension
- Heart Failure
- Myocardial infarction within 6 months
Show all 10Show fewer
- Angina pectoris, clinically significant valvular disease or arrhythmia
- Alteration indices of liver function or renal
- Known hypersensitivity to ACE inhibitors
- All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia, PV, 27100
Amedeo Mugellini, MD, +39 0382 526217, amedeo.mugellini@unipv.it
Amedeo Mugellini, MD
About this study
The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:
- Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
- Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
- Conditions
- Hypertension, Type 2 Diabetes
- Being tested
- Ramipril, Experimental
- Keywords
- Hypertension, type 2 diabetes, aliskiren, ramipril, microalbuminuria, blood pressure> 130/80 <180/105 mmHg at the end of the wash-out, type 2 diabetes mellitus well controlled by medication and / or, compliance with diet (HbA1c <7%), Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
tablet; 10 mg; od; 3 months
ExperimentalDrug
tablet; 300 mg; od; 3 months
| Study group | Role | What they receive |
|---|---|---|
| Ramipril | Active comparator | 10 mg/daily Receives: Drug: Ramipril |
| Aliskiren | Experimental | 300 mg/ daily Receives: Drug: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
Measured: 3 months
Secondary outcomes (3)
Average of 24 hours by ABPM, systolic and diastolic blood pressure
Measured: 3 months
Average daytime, systolic and diastolic blood pressure
Measured: 3 months
Average night, systolic and diastolic blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Fogari, MD, Study director, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038895
- Sponsor's protocol ID
- UNIPV002DIM2009
- Other IDs
- 2009-016481-83, 2009
- Status last verified
- Sep 2009
- First submitted
- 23 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
- ClinicalTrials.gov ID
- NCT01038895
- Acronym / sponsor ID
- UNIPV002DIM2009
- Conditions
- Hypertension, Type 2 Diabetes
- Keywords
- Hypertension, type 2 diabetes, aliskiren, ramipril, microalbuminuria, blood pressure> 130/80 <180/105 mmHg at the end of the wash-out, type 2 diabetes mellitus well controlled by medication and / or, compliance with diet (HbA1c <7%)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 24 Dec 2009 (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 main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:
- Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
- Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramipril | Active comparator | Drug: Ramipril10 mg/daily |
| Aliskiren | Experimental | Drug: Experimental300 mg/ daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- blood pressure > 130/80 <180/105 mmHg at the end of the wash-out
- type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
- microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)
Key exclusion criteria (10 listed)
- Pregnancy, lactation or women of childbearing age
- Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
- History of hypertensive encephalopathy or cerebrovascular accident within 6 months
- Secondary hypertension
- Heart Failure
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 |
|---|---|---|
| Ramipriltablet; 10 mg; od; 3 months | Drug | Ramipril |
| Experimentaltablet; 300 mg; od; 3 months | Drug | Aliskiren |
Primary outcome
Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
Time frame: 3 months
3 secondary outcomes
Average of 24 hours by ABPM, systolic and diastolic blood pressure
Time frame: 3 months
Average daytime, systolic and diastolic blood pressure
Time frame: 3 months
Average night, systolic and diastolic blood pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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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.
Roberto Fogari, MD study director
University of Pavia
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 Ramipril and Experimental in people with Hypertension and Type 2 Diabetes, run by University of Pavia at 1 site in Italy.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Dec 2009. 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 Italy. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Fogari, MD (+39 0382 526217, r.fogari@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. (time frame: 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 24 Dec 2009.