HypertensionPhase 3NCT00386607
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
A Phase 3 study testing Aliskiren, Valsartan and Hydrochlorothiazide (HCTZ) in people with Hypertension, run by Novartis at 4 sites in 4 countries.
Trial summary
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ). 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, Valsartan and Hydrochlorothiazide (HCTZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2006to Jul 2008
- 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
- Male and female outpatients 18 years of age and older.
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
- Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
Who cannot join
- Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
- Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
- Conditions
- Hypertension
- Being tested
- Aliskiren, Valsartan, Hydrochlorothiazide (HCTZ)
- Keywords
- Hypertension, aliskiren, valsartan, HCTZ, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Aliskiren 300 mg
ValsartanDrug
Valsartan 320 mg
Hydrochlorothiazide (HCTZ)Drug
Hydrochlorothiazide (HCTZ) 12.5-25 mg
| Study group | Role | What they receive |
|---|---|---|
| Core Treatment | Experimental | Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled. Receives: Drug: Aliskiren; Drug: Valsartan |
| Extension Treatment | Experimental | For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.
The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits. Receives: Drug: Aliskiren; Drug: Valsartan; Drug: Hydrochlorothiazide (HCTZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Percentage of Patients With Adverse Events
Measured: Month 12
Overall Percentage of Patients With Adverse Events
adverse event data obtained from both the core study and the 6 month extension study.
Measured: Month 18
Secondary outcomes (6)
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Measured: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Measured: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Measured: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure
Measured: Baseline and Month 18
Change From Baseline in Mean Sitting Systolic Blood Pressure
Measured: Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2008
- Study completionJul 2008
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
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
- NCT00386607
- Sponsor's protocol ID
- CSPV100A2301
- Other IDs
- CSPV100A2301E1
- Status last verified
- Jan 2014
- First submitted
- 10 Oct 2006
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.
PubMed 21062137
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)
- ClinicalTrials.gov ID
- NCT00386607
- Acronym / sponsor ID
- CSPV100A2301
- Conditions
- Hypertension
- Keywords
- Hypertension, aliskiren, valsartan, HCTZ, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Treatment | Experimental | Drug: Aliskiren, Drug: ValsartanOral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled. |
| Extension Treatment | Experimental | Drug: Aliskiren, Drug: Valsartan, Drug: Hydrochlorothiazide (HCTZ)For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg. The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female outpatients 18 years of age and older.
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
- Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
Key exclusion criteria (5 listed)
- Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
- Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
- 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 |
|---|---|---|
| AliskirenAliskiren 300 mg | Drug | Core Treatment, Extension Treatment |
| ValsartanValsartan 320 mg | Drug | Core Treatment, Extension Treatment |
| Hydrochlorothiazide (HCTZ)Hydrochlorothiazide (HCTZ) 12.5-25 mg | Drug | Extension Treatment |
Primary outcome
Overall Percentage of Patients With Adverse Events
Time frame: Month 12
Overall Percentage of Patients With Adverse Events
Time frame: Month 18
adverse event data obtained from both the core study and the 6 month extension study.
6 secondary outcomes
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Time frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure
Time frame: Baseline and Month 18
Change From Baseline in Mean Sitting Systolic Blood Pressure
Time frame: Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21062137Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.
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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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren, Valsartan and Hydrochlorothiazide (HCTZ) in people with Hypertension, run by Novartis at 4 sites in 4 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 4 inclusion and 5 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Germany, Netherlands. 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 10 May 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?
Overall Percentage of Patients With Adverse Events (time frame: Month 12). The study lists 2 primary outcomes in all. 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 NCT00386607, 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 10 Feb 2014.