High Blood PressurePhase 4ANDROMEDANCT01056731
A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.
A Phase 4 study testing Aliskiren and HCTZ in people with High Blood Pressure, run by Novartis at 7 sites in Venezuela.
Trial summary
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Aliskiren and HCTZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 7 sitesVenezuela
- Study dates
- Feb 2010to Oct 2011
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.
Who cannot join
- BP> 180/110 mmHg
- Pregnant or nursing women
- Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
- K <3.5 mEq/L or ≥ 5 mEq/L
- Renal impairment
- Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Venezuela7 sites
Investigative Site
Bolíva
Investigative Site
Carabobo
Investigative Site
Caracas
Investigative Site
Edo Zulia
Investigative Site
Estado Monagas
Investigative Site
Falcón
Investigative Site
Maracaibo Estado Zulia
About this study
Official title: A 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
- Conditions
- High Blood Pressure
- Being tested
- Aliskiren and HCTZ
- Keywords
- high blood pressure, aliskiren, hydrochlorothiazide, control rate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren and HCTZDrug
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren and Aliskiren_HCTZ | Experimental | aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg Receives: Drug: Aliskiren and HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in whom BP control was achieved at the study end point
Measured: 16 weeks
Secondary outcomes (4)
The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point
Measured: 8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
Measured: 16 weeks
Change in msSPA and msDBP from baseline to different time points
Measured: 4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points
Measured: 4,8,12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056731
- Sponsor's protocol ID
- CSPP100AVE01
- Acronym
- ANDROMEDA
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II
- ClinicalTrials.gov ID
- NCT01056731
- Acronym / sponsor ID
- ANDROMEDA / CSPP100AVE01
- Conditions
- High Blood Pressure
- Keywords
- high blood pressure, aliskiren, hydrochlorothiazide, control rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jan 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.
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliskiren and Aliskiren_HCTZ | Experimental | Drug: Aliskiren and HCTZaliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.
Key exclusion criteria (7 listed)
- BP> 180/110 mmHg
- Pregnant or nursing women
- Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
- K <3.5 mEq/L or ≥ 5 mEq/L
- Renal impairment
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 and HCTZAliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg | Drug | Aliskiren and Aliskiren_HCTZ |
Primary outcome
The proportion of patients in whom BP control was achieved at the study end point
Time frame: 16 weeks
4 secondary outcomes
The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point
Time frame: 8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
Time frame: 16 weeks
Change in msSPA and msDBP from baseline to different time points
Time frame: 4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points
Time frame: 4,8,12 and 16 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and HCTZ in people with High Blood Pressure, run by Novartis at 7 sites in Venezuela.
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 1 inclusion and 7 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 7 sites in Venezuela. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients in whom BP control was achieved at the study end point (time frame: 16 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.