HypertensionPhase 2NCT01692301
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
A Phase 2 study testing LCZ696, Olmesartan and amlodipine in people with Hypertension, run by Novartis Pharmaceuticals at 47 sites in 12 countries.
Trial summary
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- LCZ696, Olmesartan and amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 47 sitesin 12 countries
- Study dates
- Dec 2012to Apr 2015
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 60 years of age.
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
- Untreated patients must have an office msSBP ≥150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
- Treated patients must have an office msSBP ≥140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
- All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
- Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.
Who cannot join
- Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
- History of angioedema, drug-related or otherwise.
- History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
- Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
- History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
- History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.
Trial locations and contacts
47 sites in 12 countries.
47 sites in 12 countries
United States11 sites
Novartis Investigative Site
Baltimore, Maryland, 21204
Novartis Investigative Site
Belzoni, Mississippi, 39038
Novartis Investigative Site
Buffalo, New York, 14215
Novartis Investigative Site
Chicago, Illinois, 60607
Novartis Investigative Site
Cincinnati, Ohio, 45224
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Houston, Texas, 77081
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Lake Jackson, Texas, 77566
Novartis Investigative Site
Pasadena, Texas, 77504
Novartis Investigative Site
St Louis, Missouri, 63141
Spain10 sites
Novartis Investigative Site
A Coruña, Galicia, 15706
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08025
Novartis Investigative Site
Centelles, Catalonia, 08540
Novartis Investigative Site
Jerez de la Frontera, Cadiz, 11407
Novartis Investigative Site
Madrid, Madrid, 28034
Novartis Investigative Site
Madrid, Madrid, 28041
Novartis Investigative Site
Port de Sagunt, Valencia, 46520
Novartis Investigative Site
Seville, Andalusia, 41071
Novartis Investigative Site
Terrassa, Catalonia, 08221
Russia6 sites
Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Yaroslavl, 150047
Argentina3 sites
Novartis Investigative Site
Caba, Buenos Aires, C1440AAD
Novartis Investigative Site
Ramos Mejía, Buenos Aires, B1704ETD
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH
Greece3 sites
Novartis Investigative Site
Athens, Athens, 11525
Novartis Investigative Site
Athens, Athens, 11526
Novartis Investigative Site
Thessaloniki, Greece, 54642
Italy3 sites
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
San Daniele del Friuli, UD, 33038
Novartis Investigative Site
Treviglio, BG, 24047
Taiwan3 sites
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan, ROC, 112
Colombia2 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Barranquilla
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Nuremberg, 90471
South Korea2 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 424-717
Novartis Investigative Site
Seoul, Korea, 110 744
About this study
Official title: A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
- Conditions
- Hypertension
- Being tested
- LCZ696, Olmesartan, LCZ696 matching placebo, Olmesartan matching placebo, amlodipine
- Keywords
- hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
Also called sacubitril/valsartan
200 mg tablet
OlmesartanDrug
20 mg and 40 mg capsules
LCZ696 matching placeboDrug
LCZ696 Matching Placebo tablet
Olmesartan matching placeboDrug
Olmesartan matching placebo capsule
amlodipineDrug
amlodipine 2.5 mg or 5 mg tablets
hydrochlorothiazideDrug
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 (sacubitril/valsartan) | Experimental | Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study. Receives: Drug: LCZ696; Drug: LCZ696 matching placebo; Drug: Olmesartan matching placebo; Drug: amlodipine; Drug: hydrochlorothiazide |
| Olmesartan | Active comparator | Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study. Receives: Drug: Olmesartan; Drug: LCZ696 matching placebo; Drug: amlodipine; Drug: hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.
At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.
Measured: baseline, 12 weeks
Secondary outcomes (10)
Change From Baseline in Mean Central Pulse (CPP) Pressure
Measured: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Pulse Wave Velocity (PWV)
Pulse wave velocity recordings were performed on patient while in a supine, face-up position.
Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52.
Measured: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.
At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.
Measured: baseline, 52 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Measured: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Measured: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Pulse Pressure (msPP)
Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.
Measured: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3.
Measured: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.
Measured: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.
Measured: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.
Measured: Baseline, 12 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692301
- Sponsor's protocol ID
- CLCZ696A2216
- Other IDs
- 2012-002899-14
- Status last verified
- Mar 2016
- First submitted
- 20 Sep 2012
- Last updated
- 4 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.
PubMed 24496699
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01692301
- Acronym / sponsor ID
- CLCZ696A2216
- Conditions
- Hypertension
- Keywords
- hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 (sacubitril/valsartan) | Experimental | Drug: LCZ696, Drug: LCZ696 matching placebo, Drug: Olmesartan matching placebo, Drug: amlodipine, Drug: hydrochlorothiazideRandomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study. |
| Olmesartan | Active comparator | Drug: Olmesartan, Drug: LCZ696 matching placebo, Drug: amlodipine, Drug: hydrochlorothiazideRandomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients ≥ 60 years of age.
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
- Untreated patients must have an office msSBP ≥150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
- Treated patients must have an office msSBP ≥140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
- All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
Key exclusion criteria (6 listed)
- Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
- History of angioedema, drug-related or otherwise.
- History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
- Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
- History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
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 |
|---|---|---|
| LCZ696Also: sacubitril/valsartan200 mg tablet | Drug | LCZ696 (sacubitril/valsartan) |
| Olmesartan20 mg and 40 mg capsules | Drug | Olmesartan |
| LCZ696 matching placeboLCZ696 Matching Placebo tablet | Drug | LCZ696 (sacubitril/valsartan), Olmesartan |
| Olmesartan matching placeboOlmesartan matching placebo capsule | Drug | LCZ696 (sacubitril/valsartan) |
| amlodipineamlodipine 2.5 mg or 5 mg tablets | Drug | LCZ696 (sacubitril/valsartan), Olmesartan |
| hydrochlorothiazidehydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets | Drug | LCZ696 (sacubitril/valsartan), Olmesartan |
Primary outcome
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
Time frame: baseline, 12 weeks
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.
10 secondary outcomes
Change From Baseline in Mean Central Pulse (CPP) Pressure
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Pulse Wave Velocity (PWV)
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
Time frame: baseline, 52 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Pulse Pressure (msPP)
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Arterial Pressure (MAP)
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
Time frame: Baseline, 12 weeks, and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24496699Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.
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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
47 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCZ696, Olmesartan and amlodipine in people with Hypertension, run by Novartis Pharmaceuticals at 47 sites in 12 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 6 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Spain, Russia, Argentina, Greece and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 May 2016). 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 Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks (time frame: baseline, 12 weeks). 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 NCT01692301, 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 4 May 2016.