Moderate to Severe HypertensionPhase 3NCT00841672
Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
A Phase 3 study testing Aliskiren/amlodipine 300/10 mg tablet and Amlodipine 10 mg capsule in people with Moderate to Severe Hypertension, run by Novartis at 6 sites in 6 countries.
Trial summary
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Hypertension
- What is being tested?
- Aliskiren/amlodipine 300/10 mg tablet and Amlodipine 10 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jan 2009to Sep 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
- Outpatients ≥ 18 years of age
- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2
Who cannot join
- Mild to moderate 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
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- 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
- Patients on a combination of 3 or more antihypertensive medications
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
- Conditions
- Moderate to Severe Hypertension
- Being tested
- Aliskiren/amlodipine 300/10 mg tablet, Amlodipine 10 mg capsule
- Keywords
- Hypertension, systolic blood pressure, cardiovascular disease, aliskiren, amlodipine
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren/amlodipine 300/10 mg tabletDrug
Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
Amlodipine 10 mg capsuleDrug
Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | Experimental | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. Receives: Drug: Aliskiren/amlodipine 300/10 mg tablet |
| Amlodipine 10 mg capsule | Active comparator | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. Receives: Drug: Amlodipine 10 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sitting Systolic Blood Pressure (msSBP)
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
Measured: Baseline to end of study (Week 8)
Secondary outcomes (4)
Mean Sitting Diastolic Blood Pressure (msDBP)
Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)
Measured: Baseline to end of study (Week 8)
Systolic Blood Pressure Response
Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)
Measured: Baseline to end of study (Week 8)
Diastolic Blood Pressure Response
Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)
Measured: Baseline to end of study (Week 8)
Blood Pressure Control
Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study
Measured: End of study (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 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.
- Other trials for Moderate to Severe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841672
- Sponsor's protocol ID
- CSPA100A2306
- Status last verified
- Jul 2011
- First submitted
- 10 Feb 2009
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
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
- An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
- ClinicalTrials.gov ID
- NCT00841672
- Acronym / sponsor ID
- CSPA100A2306
- Conditions
- Moderate to Severe Hypertension
- Keywords
- Hypertension, systolic blood pressure, cardiovascular disease, aliskiren, amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Posted 27 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 compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | Experimental | Drug: Aliskiren/amlodipine 300/10 mg tabletAliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
| Amlodipine 10 mg capsule | Active comparator | Drug: Amlodipine 10 mg capsuleAmlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
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
- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2
Key exclusion criteria (10 listed)
- Mild to moderate 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/amlodipine 300/10 mg tabletEach dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. | Drug | Aliskiren/amlodipine 300/10 mg tablet |
| Amlodipine 10 mg capsuleEach dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. | Drug | Amlodipine 10 mg capsule |
Primary outcome
Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline to end of study (Week 8)
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
4 secondary outcomes
Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline to end of study (Week 8)
Systolic Blood Pressure Response
Time frame: Baseline to end of study (Week 8)
Diastolic Blood Pressure Response
Time frame: Baseline to end of study (Week 8)
Blood Pressure Control
Time frame: End of study (Week 8)
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.
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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 director
Novartis
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren/amlodipine 300/10 mg tablet and Amlodipine 10 mg capsule in people with Moderate to Severe Hypertension, run by Novartis at 6 sites in 6 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 10 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 6 sites in Germany, Philippines, Romania, Russia, Singapore and 1 more country. 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 27 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?
Mean Sitting Systolic Blood Pressure (msSBP) (time frame: Baseline to 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?
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.