HypertensionPhase 3NCT00518765
Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet
A Phase 3 study testing Aliskiren in people with Hypertension, run by Novartis at 1 site in United States.
Trial summary
This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2007
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects age 18 to 75 years of age included
- Strictly adhere to provided diet.
Who cannot join
- Symptomatic low blood pressure
- Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
- Over-the-counter medication 2 weeks before study start
- Clinically significant heart abnormalities.
- Previous history of allergy to the study drug or drugs similar to the study drug.
- Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet "Renin Inhibition and the Kidney"
This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.
- Conditions
- Hypertension
- Being tested
- Aliskiren, Aliskiren plus placebo
- Keywords
- aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called SPP100
Aliskiren plus placeboDrug
AliskirenDrug
Also called SPP100
Aliskiren plus placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Various sequences of different doses of Aliskiren Receives: Drug: Aliskiren |
| 2 | Experimental | Various sequences of different doses of Aliskiren plus placebo Receives: Drug: Aliskiren plus placebo |
| 3 | Experimental | Various sequences of different doses of Aliskiren Receives: Drug: Aliskiren |
| 4 | Experimental | Various sequences of different doses of Aliskiren plus placebo Receives: Drug: Aliskiren plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
Measured: baseline and hourly intervals.
Secondary outcomes (1)
Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway
Measured: baseline, and at 5 hours, and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startOct 2005
- Primary completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518765
- Sponsor's protocol ID
- CSPP100A2318
- Status last verified
- Oct 2010
- First submitted
- 20 Aug 2007
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Fisher ND, Jan Danser AH, Nussberger J, Dole WP, Hollenberg NK. Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans. Circulation. 2008 Jun 24;117(25):3199-205. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.
PubMed 18559696
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet "Renin Inhibition and the Kidney"
- ClinicalTrials.gov ID
- NCT00518765
- Acronym / sponsor ID
- CSPP100A2318
- Conditions
- Hypertension
- Keywords
- aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2007 (actual)
- First posted
- 21 Aug 2007 (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.
This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AliskirenVarious sequences of different doses of Aliskiren |
| 2 | Experimental | Drug: Aliskiren plus placeboVarious sequences of different doses of Aliskiren plus placebo |
| 3 | Experimental | Drug: AliskirenVarious sequences of different doses of Aliskiren |
| 4 | Experimental | Drug: Aliskiren plus placeboVarious sequences of different doses of Aliskiren plus placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects age 18 to 75 years of age included
- Strictly adhere to provided diet.
Key exclusion criteria (7 listed)
- Symptomatic low blood pressure
- Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
- Over-the-counter medication 2 weeks before study start
- Clinically significant heart abnormalities.
- Previous history of allergy to the study drug or drugs similar to the study drug.
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 |
|---|---|---|
| AliskirenAlso: SPP100 | Drug | 1 |
| Aliskiren plus placebo | Drug | 2 |
| AliskirenAlso: SPP100 | Drug | 3 |
| Aliskiren plus placebo | Drug | 4 |
Primary outcome
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
Time frame: baseline and hourly intervals.
1 secondary outcome
Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway
Time frame: baseline, and at 5 hours, and 24 hours post dose
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 6 Oct 2010.
- Derived from this study: PubMed 18559696Fisher ND, Jan Danser AH, Nussberger J, Dole WP, Hollenberg NK. Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans. Circulation. 2008 Jun 24;117(25):3199-205. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.
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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 principal investigator
Investigative site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren in people with 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 2 inclusion and 7 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 6 Oct 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet (time frame: baseline and hourly intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518765, which also lists 1 linked publication.
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 6 Oct 2010.