HypertensionPhase 3NCT00777946
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
A Phase 3 study testing Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg and Aliskiren/Amlodipine 300/10 mg in people with Hypertension, run by Novartis at 9 sites in 9 countries.
Trial summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren 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?
- Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg and Aliskiren/Amlodipine 300/10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 818 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Oct 2008to May 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 mean sitting Diastolic Blood Pressure (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 4
Who cannot join
- Severe hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- Uncontrolled Type 1 or Type 2 diabetes mellitus
Show all 9Show fewer
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 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 (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
- Conditions
- Hypertension
- Being tested
- Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg, Aliskiren/Amlodipine 300/10 mg, Placebo to Aliskiren, Placebo to Aliskiren/Amlodipine
- Keywords
- Aliskiren, Amlodipine, Non-responder to aliskiren
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren 300 mgDrug
Aliskiren 300 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/5 mgDrug
Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/10 mgDrug
Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
Placebo to AliskirenDrug
Placebo to Aliskiren tablet taken orally once a day.
Placebo to Aliskiren/AmlodipineDrug
Placebo to Aliskiren/Amlodipine taken orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren 300 mg/Amlodipine 5 mg | Experimental | Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. Receives: Drug: Aliskiren/Amlodipine 300/5 mg; Drug: Placebo to Aliskiren |
| Aliskiren 300 mg/Amlodipine 10 mg | Experimental | Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. Receives: Drug: Aliskiren/Amlodipine 300/10 mg; Drug: Placebo to Aliskiren |
| Aliskiren 300 mg | Active comparator | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. Receives: Drug: Aliskiren 300 mg; Drug: Placebo to Aliskiren/Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
Measured: Baseline, End of Study (Week 8)
Secondary outcomes (5)
Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
Measured: Baseline, End of Study (Week 8)
Number of Participants With Serious Adverse Events and Adverse Events
The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.
Additional information about Adverse Events can be found in the Adverse Event Section.
Measured: 8 weeks
Percentage of Participants Achieving Blood Pressure Control
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140.
Measured: 8 weeks
Percentage of Participants Achieving a Diastolic Blood Pressure Response
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.
Measured: 8 weeks
Percentage of Participants Achieving a Systolic Blood Pressure Response
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 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
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777946
- Sponsor's protocol ID
- CSPA100A2303
- Status last verified
- Jun 2011
- First submitted
- 20 Oct 2008
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765.
PubMed 22303910
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. 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 (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00777946
- Acronym / sponsor ID
- CSPA100A2303
- Conditions
- Hypertension
- Keywords
- Aliskiren, Amlodipine, Non-responder to aliskiren
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 15 Jun 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 not adequately controlled with aliskiren alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aliskiren 300 mg/Amlodipine 5 mg | Experimental | Drug: Aliskiren/Amlodipine 300/5 mg, Drug: Placebo to AliskirenParticipants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
| Aliskiren 300 mg/Amlodipine 10 mg | Experimental | Drug: Aliskiren/Amlodipine 300/10 mg, Drug: Placebo to AliskirenParticipants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. |
| Aliskiren 300 mg | Active comparator | Drug: Aliskiren 300 mg, Drug: Placebo to Aliskiren/AmlodipineParticipants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
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 mean sitting Diastolic Blood Pressure (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 4
Key exclusion criteria (9 listed)
- Severe hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
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 300 mgAliskiren 300 mg tablet taken orally once a day with a glass of water. | Drug | Aliskiren 300 mg |
| Aliskiren/Amlodipine 300/5 mgAliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. | Drug | Aliskiren 300 mg/Amlodipine 5 mg |
| Aliskiren/Amlodipine 300/10 mgAliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. | Drug | Aliskiren 300 mg/Amlodipine 10 mg |
| Placebo to AliskirenPlacebo to Aliskiren tablet taken orally once a day. | Drug | Aliskiren 300 mg/Amlodipine 10 mg, Aliskiren 300 mg/Amlodipine 5 mg |
| Placebo to Aliskiren/AmlodipinePlacebo to Aliskiren/Amlodipine taken orally once a day. | Drug | Aliskiren 300 mg |
Primary outcome
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, End of Study (Week 8)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
5 secondary outcomes
Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, End of Study (Week 8)
Number of Participants With Serious Adverse Events and Adverse Events
Time frame: 8 weeks
Percentage of Participants Achieving Blood Pressure Control
Time frame: 8 weeks
Percentage of Participants Achieving a Diastolic Blood Pressure Response
Time frame: 8 weeks
Percentage of Participants Achieving a Systolic Blood Pressure Response
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22303910Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765.
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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
Novartis
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg and Aliskiren/Amlodipine 300/10 mg in people with Hypertension, run by Novartis at 9 sites in 9 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 9 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Estonia, France, Iceland, India, Italy and 4 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 15 Jun 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 From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) (time frame: Baseline, End of Study (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 NCT00777946, 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 12 Jul 2011.