HypertensionPhase 3NCT00262236
Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension
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 the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 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
- 693 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2005to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients 18 years of age and older.
- Patients with essential hypertension.
Who cannot join
- Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.
- Conditions
- Hypertension
- Being tested
- Aliskiren
- Keywords
- Hypertension, Aliskiren, Atenolol, 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 12 weeks
Secondary outcomes (3)
Change from baseline in systolic blood pressure after 12 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
Blood pressure of < 140/90 mmHg after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 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
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceutical, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262236
- Sponsor's protocol ID
- CSPP100A2304
- Status last verified
- Nov 2016
- First submitted
- 2 Dec 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Dietz R, Dechend R, Yu CM, Bheda M, Ford J, Prescott MF, Keefe DL. Effects of the direct renin inhibitor aliskiren and atenolol alone or in combination in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2008 Sep;9(3):163-75. doi: 10.1177/1470320308096411.
PubMed 18957387
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00262236
- Acronym / sponsor ID
- CSPP100A2304
- Conditions
- Hypertension
- Keywords
- Hypertension, Aliskiren, Atenolol, Blood Pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 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 the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 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
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients 18 years of age and older.
- Patients with essential hypertension.
Key exclusion criteria (2 listed)
- Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,
- 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 12 weeks
3 secondary outcomes
Change from baseline in systolic blood pressure after 12 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
Blood pressure of < 140/90 mmHg after 12 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 18 Nov 2016.
- Results publication: PubMed 18957387Dietz R, Dechend R, Yu CM, Bheda M, Ford J, Prescott MF, Keefe DL. Effects of the direct renin inhibitor aliskiren and atenolol alone or in combination in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2008 Sep;9(3):163-75. doi: 10.1177/1470320308096411.
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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 Pharmaceutical study director
Novartis Pharmaceuticals
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 2 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 18 Nov 2016. 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 Germany, Switzerland. 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 12 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 NCT00262236, 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 18 Nov 2016.