HypertensionPhase 3NCT00778921
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone
A Phase 3 study testing Amlodipine 10 mg, Aliskiren 150 and Amlodipine 300 in people with Hypertension, run by Novartis at 7 sites in 7 countries.
Trial summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine 10 mg, Aliskiren 150 and Amlodipine 300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 847 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Oct 2008to Jun 2009
- 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
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)
Who cannot join
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- History of cardiovascular conditions
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
- Conditions
- Hypertension
- Being tested
- Amlodipine 10 mg, Aliskiren 150, Amlodipine 300
- Keywords
- Aliskiren, Amlodipine, Non-responder to Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 10 mgDrug
Amlodipine 10 mg
Aliskiren 150Drug
Aliskiren/Amlodipine 150/10 mg
Amlodipine 300Drug
Aliskiren/Amlodipine 300/10 mg
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine 10 mg | Experimental | Amlodipine 10 mg Receives: Drug: Amlodipine 10 mg |
| Aliskiren/Amlodipine 150/10 mg | Experimental | Aliskiren/Amlodipine 150/10 mg Receives: Drug: Amlodipine 10 mg; Drug: Aliskiren 150 |
| Aliskiren/Amlodipine 300/10 mg | Experimental | Aliskiren/Amlodipine 300/10 mg Receives: Drug: Amlodipine 10 mg; Drug: Amlodipine 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Measured: Baseline and Week 8
Secondary outcomes (3)
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
Measured: Baseline and Week 8
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
Measured: 8 weeks
Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 847 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778921
- Sponsor's protocol ID
- CSPA100A2304
- Status last verified
- Feb 2011
- First submitted
- 23 Oct 2008
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945.
PubMed 22303911
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00778921
- Acronym / sponsor ID
- CSPA100A2304
- Conditions
- Hypertension
- Keywords
- Aliskiren, Amlodipine, Non-responder to Amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 847 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 23 Mar 2011
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 assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amlodipine 10 mg | Experimental | Drug: Amlodipine 10 mgAmlodipine 10 mg |
| Aliskiren/Amlodipine 150/10 mg | Experimental | Drug: Amlodipine 10 mg, Drug: Aliskiren 150Aliskiren/Amlodipine 150/10 mg |
| Aliskiren/Amlodipine 300/10 mg | Experimental | Drug: Amlodipine 10 mg, Drug: Amlodipine 300Aliskiren/Amlodipine 300/10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)
Key exclusion criteria (8 listed)
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- History of cardiovascular conditions
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 |
|---|---|---|
| Amlodipine 10 mgAmlodipine 10 mg | Drug | Aliskiren/Amlodipine 150/10 mg, Aliskiren/Amlodipine 300/10 mg, Amlodipine 10 mg |
| Aliskiren 150Aliskiren/Amlodipine 150/10 mg | Drug | Aliskiren/Amlodipine 150/10 mg |
| Amlodipine 300Aliskiren/Amlodipine 300/10 mg | Drug | Aliskiren/Amlodipine 300/10 mg |
Primary outcome
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Time frame: Baseline and Week 8
3 secondary outcomes
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
Time frame: Baseline and Week 8
Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
Time frame: 8 weeks
Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22303911Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945.
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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 study chair
N
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine 10 mg, Aliskiren 150 and Amlodipine 300 in people with Hypertension, run by Novartis at 7 sites in 7 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 3 inclusion and 8 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Argentina, Germany, Norway, Poland, Slovakia and 2 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 23 Mar 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?
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (time frame: Baseline and Week 8). 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 NCT00778921, 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 27 Oct 2016.