HypertensionPhase 3NCT00387517
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
A Phase 3 study testing Aliskiren/HCTZ in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period. 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/HCTZ
- How many people
- 726 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2006to Aug 2007
- 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
- Male or female outpatients 18 years old or older.
- Patients with a diagnosis of hypertension defined as follows:
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
- All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
- All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.
- Patients who are eligible and consent to participate in the study
Who cannot join
- Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
- Previous or current diagnosis of heart failure.
- History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.
- Conditions
- Hypertension
- Being tested
- Aliskiren/HCTZ
- Keywords
- Diastolic, systolic, hypertension, aliskiren, blood pressure, hydrochlorothiazide, HCTZ
- Medical subject headings
- Hypertension, Heart Murmurs, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren/HCTZDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
Secondary outcomes (3)
Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
Safety and tolerability
Proportion of patients achieving a blood pressure control target at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionAug 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 726 participants (estimated)
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
- NCT00387517
- Sponsor's protocol ID
- CSPP100A2333
- Status last verified
- Feb 2017
- First submitted
- 11 Oct 2006
- Last updated
- 7 Feb 2017
- Results posted
- No
Publications
Blumenstein M, Romaszko J, Calderon A, Andersen K, Ibram G, Liu Z, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. Curr Med Res Opin. 2009 Apr;25(4):903-10. doi: 10.1185/03007990902804158.
PubMed 19245300
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00387517
- Acronym / sponsor ID
- CSPP100A2333
- Conditions
- Hypertension
- Keywords
- Diastolic, systolic, hypertension, aliskiren, blood pressure, hydrochlorothiazide, HCTZ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 13 Oct 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.
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female outpatients 18 years old or older.
- Patients with a diagnosis of hypertension defined as follows:
- Patients who are eligible and consent to participate in the study
Key exclusion criteria (4 listed)
- Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
- Previous or current diagnosis of heart failure.
- History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
- 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 |
|---|---|---|
| Aliskiren/HCTZ | Drug | – |
Primary outcome
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
3 secondary outcomes
Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
Safety and tolerability
Proportion of patients achieving a blood pressure control target at week 8
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 7 Feb 2017.
- Results publication: PubMed 19245300Blumenstein M, Romaszko J, Calderon A, Andersen K, Ibram G, Liu Z, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. Curr Med Res Opin. 2009 Apr;25(4):903-10. doi: 10.1185/03007990902804158.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren/HCTZ in people with Hypertension, run by Novartis at 2 sites in 2 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 6 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 7 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 2 sites in United States, Germany. 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?
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.. 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 NCT00387517, 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 7 Feb 2017.