HypertensionPhase 4NCT01048047
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
A Phase 4 study testing aliskiren/amlodipine in people with Hypertension, run by University of Pavia at 2 sites in Italy.
Trial summary
Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- aliskiren/amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2009to Mar 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diastolic blood pressure > 95 mmHg and < 110 mmHg
- systolic blood pressure > 140 mmHg and < 180 mmHg
- no amlodipine therapy for the previous 6 months
Who cannot join
- diastolic blood pressure > 110 mmHg and or
- systolic blood pressure > 180 mmHg
- secondary hypertension
- heart failure
- diabetes mellitus
- liver or kidney diseases
Trial locations and contacts
2 sites in 1 country.
About this study
Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.
- Conditions
- Hypertension
- Being tested
- aliskiren/amlodipine
- Keywords
- aliskiren, amlodipine, hypertension, ankle-foot volume, mild and moderate hypertension
- Medical subject headings
- Hypertension, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskiren/amlodipineDrug
aliskiren 300 mg /amlodipine 10 mg
| Study group | Role | What they receive |
|---|---|---|
| aliskiren/amlodipine | Experimental | aliskiren, 300 mg/amlodipine 10 mg Receives: Drug: aliskiren/amlodipine |
| amlodipine | Active comparator | amlodipine 10 mg Receives: Drug: aliskiren/amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure, heart rate, ankle-foot volume
Measured: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Secondary outcomes (1)
Blood pressure and heart rate in sitting and standing position
Measured: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Fogari, MD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048047
- Sponsor's protocol ID
- UNIPV001DIM2009
- Other IDs
- EudraCT 2009
- Status last verified
- Nov 2009
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01048047
- Acronym / sponsor ID
- UNIPV001DIM2009
- Conditions
- Hypertension
- Keywords
- aliskiren, amlodipine, hypertension, ankle-foot volume, mild and moderate hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Jan 2010 (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.
Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aliskiren/amlodipine | Experimental | Drug: aliskiren/amlodipinealiskiren, 300 mg/amlodipine 10 mg |
| amlodipine | Active comparator | Drug: aliskiren/amlodipineamlodipine 10 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diastolic blood pressure > 95 mmHg and < 110 mmHg
- systolic blood pressure > 140 mmHg and < 180 mmHg
- no amlodipine therapy for the previous 6 months
Key exclusion criteria (6 listed)
- diastolic blood pressure > 110 mmHg and or
- systolic blood pressure > 180 mmHg
- secondary hypertension
- heart failure
- diabetes mellitus
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/amlodipinealiskiren 300 mg /amlodipine 10 mg | Drug | aliskiren/amlodipine, amlodipine |
Primary outcome
Blood pressure, heart rate, ankle-foot volume
Time frame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
1 secondary outcome
Blood pressure and heart rate in sitting and standing position
Time frame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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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 principal investigator
University of Pavia
2 sites 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/amlodipine in people with Hypertension, run by University of Pavia at 2 sites 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 6 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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Blood pressure, heart rate, ankle-foot volume (time frame: At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks). 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 13 Jan 2010.