HypertensionPhase 3NCT00260923
A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure
A Phase 3 study testing aliskiren in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- aliskiren
- How many people
- 641 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2005to Nov 2006
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Male and female outpatients 18 years of age and older
- Patients who are eligible and able to participate in the study
Who cannot join
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of hypertensive encephalopathy or cerebrovascular accident.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks
- Conditions
- Hypertension
- Being tested
- aliskiren
- Keywords
- hypertension, aliskiren, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskirenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes (2)
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2006
- Study completionNov 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260923
- Sponsor's protocol ID
- CSPP100A2328
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2005
- Last updated
- 8 Nov 2011
- Results posted
- No
Publications
Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose--response relationship of aliskiren, a direct renin inhibitor, in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clin Ther. 2009 Dec;31(12):2839-50. doi: 10.1016/j.clinthera.2009.12.006.
PubMed 20110023
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00260923
- Acronym / sponsor ID
- CSPP100A2328
- Conditions
- Hypertension
- Keywords
- hypertension, aliskiren, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 2 Dec 2005 (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 is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female outpatients 18 years of age and older
- Patients who are eligible and able to participate in the study
Key exclusion criteria (4 listed)
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of hypertensive encephalopathy or cerebrovascular accident.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aliskiren | Drug | – |
Primary outcome
Change from baseline in diastolic blood pressure after 8 weeks
2 secondary outcomes
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
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 8 Nov 2011.
- Derived from this study: PubMed 20110023Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose--response relationship of aliskiren, a direct renin inhibitor, in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clin Ther. 2009 Dec;31(12):2839-50. doi: 10.1016/j.clinthera.2009.12.006.
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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
Sponsor GmbH
2 sites in 2 countries: 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 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 8 Nov 2011. 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 United States, Germany. 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?
Change from baseline in diastolic blood pressure after 8 weeks. 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 NCT00260923, 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 8 Nov 2011.