HypertensionPhase 2NCT00311012
SPP100 Dose Finding Study in Japan
A Phase 2 study testing Aliskiren in people with Hypertension, run by Novartis at 1 site in Japan.
Trial summary
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren
- How many people
- 445 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2004to Mar 2005
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate essential hypertension
- Age: ≥20 years old and <80 years old (at time informed consent obtained)
- Sex: N/A
- Admission status: Outpatient
Who cannot join
- Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
- Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
- Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
- Patients suspected of having malignant hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-finding Study of SPP100 in Essential Hypertension
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.
- Conditions
- Hypertension
- Being tested
- Aliskiren
- Keywords
- Hypertension, Aliskiren
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Secondary outcomes (3)
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startAug 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Japan, Principal investigator, Novartis Pharmaceuticals, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311012
- Sponsor's protocol ID
- CSPP100A1201
- Status last verified
- Jun 2006
- First submitted
- 31 Mar 2006
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study of SPP100 in Essential Hypertension
- ClinicalTrials.gov ID
- NCT00311012
- Acronym / sponsor ID
- CSPP100A1201
- Conditions
- Hypertension
- Keywords
- Hypertension, Aliskiren
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 5 Apr 2006 (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.
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate essential hypertension
- Age: ≥20 years old and <80 years old (at time informed consent obtained)
- Sex: N/A
- Admission status: Outpatient
Key exclusion criteria (4 listed)
- Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
- Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
- Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
- Patients suspected of having malignant hypertension
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 | Drug | – |
Primary outcome
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
3 secondary outcomes
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 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 8 Nov 2011.
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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, Japan principal investigator
Novartis Pharmaceuticals, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aliskiren in people with Hypertension, run by Novartis at 1 site 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 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in mean sitting diastolic blood pressure after 8 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 8 Nov 2011.