HypertensionPhase 3NCT00171405
A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
A Phase 3 study testing aliskiren in people with Hypertension, run by Novartis at 10 sites in 10 countries.
Trial summary
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg. 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
- How many people
- 250 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Jun 2005to Feb 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
- absence of ongoing severe adverse events at Visit 10.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
- Conditions
- Hypertension
- Being tested
- aliskiren
- Keywords
- hypertension, aliskiren, hydrochlorothiazide
- 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.
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
Secondary outcomes (5)
Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Blood pressure less than 140/90 mmHg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171405
- Sponsor's protocol ID
- CSPP100A2302E1
- Status last verified
- Nov 2016
- First submitted
- 24 Aug 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.
PubMed 22035463
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00171405
- Acronym / sponsor ID
- CSPP100A2302E1
- Conditions
- Hypertension
- Keywords
- hypertension, aliskiren, hydrochlorothiazide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 15 Sep 2005 (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 collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
- absence of ongoing severe adverse events at Visit 10.
Key exclusion criteria (0 listed)
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
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
5 secondary outcomes
Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Blood pressure less than 140/90 mmHg
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 18 Nov 2016.
- Results publication: PubMed 22035463Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.
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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
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aliskiren in people with Hypertension, run by Novartis at 10 sites in 10 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 0 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belgium, Canada, Germany, Italy and 5 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?
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?
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study. 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 NCT00171405, 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 18 Nov 2016.