Essential HypertensionPhase 3NCT01237873
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
A Phase 3 study testing Ali/Amlo 150/2.5 mg in people with Essential Hypertension, run by Novartis Pharmaceuticals at 13 sites in Japan.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Ali/Amlo 150/2.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesJapan
- Study dates
- Jan 2011to Feb 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that complete CSPA100A1301 study
- Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled
Who cannot join
- Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
- Presence of major protocol violation in CSPA100A1301 study
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Novartis Investigative Site
Edogawa-ku, Tokyo, 133-0061
Novartis Investigative Site
Katsushika-ku, Tokyo, 124-0024
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Koshigaya, Saitama, 343-0826
Novartis Investigative Site
Kunitachi, Tokyo, 186-0001
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Shibuya-ku, Tokyo, 150-0002
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Tachikawa, Tokyo, 190-0013
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023
About this study
Official title: A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
- Conditions
- Essential Hypertension
- Being tested
- Ali/Amlo 150/2.5 mg
- Keywords
- Aliskiren, Amlodipine, Essential hypertension, Long term
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ali/Amlo 150/2.5 mgDrug
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
| Study group | Role | What they receive |
|---|---|---|
| Ali/Amlo | Experimental | Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg Receives: Drug: Ali/Amlo 150/2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
Measured: 52 weeks
Secondary outcomes (2)
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.
Measured: 52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237873
- Sponsor's protocol ID
- CSPA100A1302
- Status last verified
- Feb 2017
- First submitted
- 29 Oct 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
- ClinicalTrials.gov ID
- NCT01237873
- Acronym / sponsor ID
- CSPA100A1302
- Conditions
- Essential Hypertension
- Keywords
- Aliskiren, Amlodipine, Essential hypertension, Long term
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Nov 2010 (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.
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ali/Amlo | Experimental | Drug: Ali/Amlo 150/2.5 mgAliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that complete CSPA100A1301 study
- Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled
Key exclusion criteria (3 listed)
- Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
- Presence of major protocol violation in CSPA100A1301 study
- 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 |
|---|---|---|
| Ali/Amlo 150/2.5 mgAliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg | Drug | Ali/Amlo |
Primary outcome
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Time frame: 52 weeks
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
2 secondary outcomes
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
Time frame: 52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
Time frame: 52 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 23 Feb 2017.
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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 director
Novartis Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ali/Amlo 150/2.5 mg in people with Essential Hypertension, run by Novartis Pharmaceuticals at 13 sites in Japan.
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 3 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. 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?
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine (time frame: 52 weeks). 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 23 Feb 2017.