HypertensionPhase 4ALLMARKNCT01176032
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
A Phase 4 study testing Aliskiren, Losartan and Amlodipine in people with Hypertension and Left Ventricle Hypertrophy, run by Novartis Pharmaceuticals at 25 sites in Spain.
Trial summary
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Left Ventricle Hypertrophy
- What is being tested?
- Aliskiren, Losartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 25 sitesSpain
- Study dates
- Jun 2010to Apr 2013
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with hypertension
- Confirmed concentric left ventricular hypertrophy:
- LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women
- Relative wall thickness > 0.42
Who cannot join
- Sever or secondary HTN
- LV ejection fraction of <40%
- Patient with compelling indication to ACEIs or ARBs or BB
- History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
- History of collagenopathies, osteopathy
- eGFR <30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L
- Morbid obesity (BMI ≥ 42 kg/m2
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Novartis Investigative Site
Alicante, Valencia, 03004
Novartis Investigative Site
Barcelona, Barcelona, 08025
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, 08006
Novartis Investigative Site
Bilbao, Basque Country, 48013
Novartis Investigative Site
Burgos, Castille and León, 09005
Novartis Investigative Site
Galdakano, Basque Country, 48960
Novartis Investigative Site
Girona, Catalonia, 17007
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, Madrid, 28009
Novartis Investigative Site
Madrid, Madrid, 28035
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Madrid, Madrid, 28041
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia
Novartis Investigative Site
Santander, 39008
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Torrevieja (Alicante), Valencia, 03186
Novartis Investigative Site
Utrera, Andalusia, 41710
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46014
Novartis Investigative Site
Vitoria-Gasteiz, Basque Country
About this study
Official title: The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.
Read the detailed description
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg).
The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (<140/90 mmHg), the dose of amlodipine was increased to 10 mg.
Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
- Conditions
- Hypertension, Left Ventricle Hypertrophy
- Being tested
- Aliskiren, Losartan, Amlodipine, Hydrochlorothiazide (HCTZ)
- Keywords
- Aliskiren, hypertension, concentric LVH, LV remodeling, LVMI, biomarkers, PICP, CT-1, MMP-1, TIMP-1, AnxA5, Aldosterone, Essential hypertension with concentric left ventricle hypertrophy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Rasilez
Aliskiren 300 mg film coated tablets
LosartanDrug
Losartan 100 mg tablets
AmlodipineDrug
Amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
Hydrochlorothiazide (HCTZ)Drug
HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Experimental | Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached. Receives: Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ) |
| Lostaran | Active comparator | Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached. Receives: Drug: Losartan; Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.
Measured: Baseline, Week 36
Secondary outcomes (19)
Change From Baseline in Biomarkers in Heart Disease
The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)
Measured: Baseline, Week 36
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)
Measured: Baseline, Week 36
Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI
Measured: Baseline, Week 36
Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)
Measured: Baseline, Week 36
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter
Measured: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)
Measured: Baseline, Week 36
Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI
Measured: Baseline, Week 36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values
Measured: Baseline, Week 10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values
Measured: Baseline, Week 10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)
Measured: Baseline, Week10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline
The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline
Measured: Week10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide
Measured: Baseline, Week 10,18,26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
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.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176032
- Sponsor's protocol ID
- CSPP100AES02
- Other IDs
- 2009-016735-36, 2009
- Acronym
- ALLMARK
- Status last verified
- Jul 2014
- First submitted
- 2 Aug 2010
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study
- ClinicalTrials.gov ID
- NCT01176032
- Acronym / sponsor ID
- ALLMARK / CSPP100AES02
- Conditions
- Hypertension, Left Ventricle Hypertrophy
- Keywords
- Aliskiren, hypertension, concentric LVH, LV remodeling, LVMI, biomarkers, PICP, CT-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Posted 24 Jul 2014
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 assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.
Detailed description
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg).
The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (<140/90 mmHg), the dose of amlodipine was increased to 10 mg.
Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Experimental | Drug: Aliskiren, Drug: Amlodipine, Drug: Hydrochlorothiazide (HCTZ)Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached. |
| Lostaran | Active comparator | Drug: Losartan, Drug: Amlodipine, Drug: Hydrochlorothiazide (HCTZ)Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with hypertension
- Confirmed concentric left ventricular hypertrophy:
- LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women
- Relative wall thickness > 0.42
Key exclusion criteria (8 listed)
- Sever or secondary HTN
- LV ejection fraction of <40%
- Patient with compelling indication to ACEIs or ARBs or BB
- History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
- History of collagenopathies, osteopathy
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 |
|---|---|---|
| AliskirenAlso: RasilezAliskiren 300 mg film coated tablets | Drug | Aliskiren |
| LosartanLosartan 100 mg tablets | Drug | Lostaran |
| AmlodipineAmlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. | Drug | Aliskiren, Lostaran |
| Hydrochlorothiazide (HCTZ)HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached. | Drug | Aliskiren, Lostaran |
Primary outcome
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
Time frame: Baseline, Week 36
PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.
19 secondary outcomes
Change From Baseline in Biomarkers in Heart Disease
Time frame: Baseline, Week 36
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
Time frame: Baseline, Week 36
Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
Time frame: Baseline, Week 36
Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
Time frame: Baseline, Week 36
Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
Time frame: Baseline, Week 36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
Time frame: Baseline, Week10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline
Time frame: Week10,18,26,36
Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
Time frame: Baseline, Week 10,18,26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
25 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, Losartan and Amlodipine in people with Hypertension and Left Ventricle Hypertrophy, run by Novartis Pharmaceuticals at 25 sites in Spain.
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 8 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2014). 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?
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP) (time frame: Baseline, Week 36). 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 24 Jul 2014.