HypertensionPhase 3NCT00402103
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
A Phase 3 study testing Aliskiren, Amlodipine and Hydrochlorothiazide in people with Hypertension, run by Novartis at 8 sites in 8 countries.
Trial summary
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg). 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, Amlodipine and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Nov 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or older
- Male or female patients are eligible
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
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
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
- Conditions
- Hypertension
- Being tested
- Aliskiren, Amlodipine, Hydrochlorothiazide
- Keywords
- Hypertension, aliskiren, amlodipine, HCTZ, 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
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
AmlodipineDrug
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
HydrochlorothiazideDrug
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren/Amlodipine | Experimental | Not described Receives: Drug: Aliskiren; Drug: Amlodipine |
| Aliskiren/Amlodipine/HCTZ | Experimental | Not described Receives: Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Percentage of Patients With Adverse Events
Measured: 52 weeks
Secondary outcomes (3)
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Measured: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Measured: Baseline, Week 2, Week 10, Week 28 and Week 54
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Measured: Baseline, Week 2, Week 10, Week 28 and Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402103
- Sponsor's protocol ID
- CSPA100A2301
- Status last verified
- Mar 2011
- First submitted
- 18 Nov 2006
- Last updated
- 10 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.
PubMed 19257800
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00402103
- Acronym / sponsor ID
- CSPA100A2301
- Conditions
- Hypertension
- Keywords
- Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 11 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren/Amlodipine | Experimental | Drug: Aliskiren, Drug: Amlodipine |
| Aliskiren/Amlodipine/HCTZ | Experimental | Drug: Aliskiren, Drug: Amlodipine, Drug: Hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients 18 years of age or older
- Male or female patients are eligible
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
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 |
|---|---|---|
| AliskirenAll patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration | Drug | Aliskiren/Amlodipine, Aliskiren/Amlodipine/HCTZ |
| AmlodipineAll patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration | Drug | Aliskiren/Amlodipine, Aliskiren/Amlodipine/HCTZ |
| HydrochlorothiazideOptional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled. | Drug | Aliskiren/Amlodipine/HCTZ |
Primary outcome
Overall Percentage of Patients With Adverse Events
Time frame: 52 weeks
3 secondary outcomes
Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
Time frame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54
Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54
Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, Week 2, Week 10, Week 28 and Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19257800Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.
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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 chair
Novartis
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren, Amlodipine and Hydrochlorothiazide in people with Hypertension, run by Novartis at 8 sites in 8 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 4 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 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Denmark, Finland, Germany and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Percentage of Patients With Adverse Events (time frame: 52 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 NCT00402103, 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 10 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.