HypertensionPhase 2NCT01870739

A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

A Phase 2 study testing sacubitril/valsartan (LCZ696), olmesartan and Amlodipine (Optional) in people with Hypertension, run by Novartis Pharmaceuticals at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: sacubitril/valsartan (LCZ696), olmesartan and Amlodipine (Optional)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 115 participants
Where: 4 sitesin 3 countries
Study dates: Oct 2013to Jun 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with essential hypertension, untreated or currently taking antihypertensive therapy

Who cannot join

women of child bearing potential (WOCBP) if not on highly effective contraception
Malignant or severe hypertension (grade 3 of WHO classification)
History or evidence of a secondary form of hypertension
Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Germany2 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Erlangen, 91054

Other trials in Germany

Switzerland1 site

Novartis Investigative Site
Basel, 4031

Other trials in Switzerland

United Kingdom1 site

Novartis Investigative Site
Glasgow, Scotland, G12 8TA

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension

This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.

Conditions: Hypertension
Being tested: sacubitril/valsartan (LCZ696), olmesartan, placebo to sacubitril/valsartan (LCZ696), placebo to olmesartan, Amlodipine (Optional)
Keywords: LCZ696,, Hypertension,, Aortic stiffness,, Central blood pressure,, Cardiovascular MRI
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sacubitril/valsartan (LCZ696)Drug
200 mg tablets
olmesartanDrug
placebo to sacubitril/valsartan (LCZ696)Other
placebo
placebo to olmesartanOther
placebo
Amlodipine (Optional)Drug
If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Study groups in NCT01870739
Study group	Role	What they receive
sacubitril/valsartan (LCZ696)	Experimental	Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks. Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure. Receives: Drug: sacubitril/valsartan (LCZ696); Other: placebo to olmesartan; Drug: Amlodipine (Optional)
olmesartan	Active comparator	Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks. Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure. Receives: Drug: olmesartan; Other: placebo to sacubitril/valsartan (LCZ696); Drug: Amlodipine (Optional)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Ascending Aorta Distensibility at 52 Week
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Measured: Baseline, 52 weeks
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Measured: Baseline, 52 weeks
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Measured: Baseline, 52 weeks

Secondary outcomes (7)

Change From Baseline in Local Aortic Strain at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.
Measured: Baseline, 52 weeks
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.
Measured: Baseline, 52 weeks
Change From Baseline in Central Blood Pressure at 52 Weeks
Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.
Measured: Baseline, 52 weeks
Change From Baseline in Augmentation Pressure at 52 Weeks
Augmentation pressure is the added pressure during systole due to wave reflection.
Measured: Baseline, 52 weeks
Change From Baseline in Augmentation Index at 52 Weeks
Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.
Measured: Baseline, 52 weeks
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.
Measured: Baseline, 52 weeks
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
This outcome measure summarizes patients with any adverse events, serious adverse events and death.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Jun 2015

First posted6 Jun 2013 (estimated)
Study startOct 2013
Primary completionJun 2015
Study completionJun 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 (2)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01870739
Sponsor's protocol ID: CLCZ696A2224
Other IDs: 2012-005720-15
Status last verified: Mar 2019
First submitted: 3 Jun 2013
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hrabak-Paar M, Kircher A, Al Sayari S, Kopp S, Santini F, Schmieder RE, Kachenoura N, Yates D, Langenickel T, Bremerich J, Heye T. Variability of MRI Aortic Stiffness Measurements in a Multicenter Clinical Trial Setting: Intraobserver, Interobserver, and Intracenter Variability of Pulse Wave Velocity and Aortic Strain Measurement. Radiol Cardiothorac Imaging. 2020 Apr 30;2(2):e190090. doi: 10.1148/ryct.2020190090. eCollection 2020 Apr.
PubMed 33778551
Santini F, Pansini M, Hrabak-Paar M, Yates D, Langenickel TH, Bremerich J, Bieri O, Schubert T. On the optimal temporal resolution for phase contrast cardiovascular magnetic resonance imaging: establishment of baseline values. J Cardiovasc Magn Reson. 2020 Oct 5;22(1):72. doi: 10.1186/s12968-020-00669-1.
PubMed 33012283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension
ClinicalTrials.gov ID: NCT01870739
Acronym / sponsor ID: CLCZ696A2224
Conditions: Hypertension
Keywords: LCZ696,, Hypertension,, Aortic stiffness,, Central blood pressure,, Cardiovascular MRI
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 6 Jun 2013 (estimated)
Results: Posted 1 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sacubitril/valsartan (LCZ696)	Experimental	Drug: sacubitril/valsartan (LCZ696), Other: placebo to olmesartan, Drug: Amlodipine (Optional)Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks. Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
olmesartan	Active comparator	Drug: olmesartan, Other: placebo to sacubitril/valsartan (LCZ696), Drug: Amlodipine (Optional)Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks. Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with essential hypertension, untreated or currently taking antihypertensive therapy

Key exclusion criteria (5 listed)

women of child bearing potential (WOCBP) if not on highly effective contraception
Malignant or severe hypertension (grade 3 of WHO classification)
History or evidence of a secondary form of hypertension
Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).

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
sacubitril/valsartan (LCZ696)200 mg tablets	Drug	sacubitril/valsartan (LCZ696)
olmesartan	Drug	olmesartan
placebo to sacubitril/valsartan (LCZ696)placebo	Other	olmesartan
placebo to olmesartanplacebo	Other	sacubitril/valsartan (LCZ696)
Amlodipine (Optional)If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen	Drug	olmesartan, sacubitril/valsartan (LCZ696)

Primary outcome

Change From Baseline in Ascending Aorta Distensibility at 52 Week
Time frame: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
Time frame: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
Time frame: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.

7 secondary outcomes

Change From Baseline in Local Aortic Strain at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline in Central Blood Pressure at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline in Augmentation Pressure at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline in Augmentation Index at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
Time frame: Baseline, 52 weeks
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
Time frame: 12 weeks

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sacubitril/Valsartan (LCZ696)	57	54
Olmesartan	57	53

Primary outcome: Change From Baseline in Ascending Aorta Distensibility at 52 Week

Time frame: Baseline, 52 weeks. Least squares mean (Standard Error). Unit: 10^(-3) x mmHg^(-1)

Measure	Sacubitril/Valsartan (LCZ696) n = 49	Olmesartan n = 53
Value	0.269 (0.1283)	0.330 (0.1233)

Sacubitril/Valsartan (LCZ696) vs Olmesartan: Mean Difference (Net): -0.0616 (95% CI -0.4178 to 0.2947), p = 0.7324, Linear Model

Population analysed: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.

Primary outcome: Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks

Time frame: Baseline, 52 weeks. Least squares mean (Standard Error). Unit: 10^(-3) x mmHg^(-1)

Measure	Sacubitril/Valsartan (LCZ696) n = 49	Olmesartan n = 53
Value	0.510 (0.1528)	0.547 (0.1469)

Sacubitril/Valsartan (LCZ696) vs Olmesartan: Mean Difference (Net): -0.0371 (95% CI -0.4582 to 0.3839), p = 0.8614, Linear Model

Primary outcome: Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks

Time frame: Baseline, 52 weeks. Least squares mean (Standard Error). Unit: 10^(-3) x mmHg^(-1)

Measure	Sacubitril/Valsartan (LCZ696) n = 49	Olmesartan n = 53
Value	0.417 (0.2242)	0.498 (0.2156)

Sacubitril/Valsartan (LCZ696) vs Olmesartan: Mean Difference (Net): -0.0812 (95% CI -0.6987 to 0.5362), p = 0.7946, Linear Model

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)	0 of 57 (0%)	3 of 57 (5.3%)	Not reported
Initiation Dose: Olmesartan 20mg	2 of 57 (3.5%)	6 of 57 (10.5%)	Not reported
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)	0 of 57 (0%)	10 of 57 (17.5%)	Not reported
Maintenance Dose: Olmesartan 40 mg	2 of 56 (3.6%)	14 of 56 (25%)	Not reported
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine	6 of 54 (11.1%)	16 of 54 (29.6%)	Not reported
Olmesartan 40mg +/- Amlodipine	5 of 53 (9.4%)	24 of 53 (45.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33778551Hrabak-Paar M, Kircher A, Al Sayari S, Kopp S, Santini F, Schmieder RE, Kachenoura N, Yates D, Langenickel T, Bremerich J, Heye T. Variability of MRI Aortic Stiffness Measurements in a Multicenter Clinical Trial Setting: Intraobserver, Interobserver, and Intracenter Variability of Pulse Wave Velocity and Aortic Strain Measurement. Radiol Cardiothorac Imaging. 2020 Apr 30;2(2):e190090. doi: 10.1148/ryct.2020190090. eCollection 2020 Apr.
Derived from this study: PubMed 33012283Santini F, Pansini M, Hrabak-Paar M, Yates D, Langenickel TH, Bremerich J, Bieri O, Schubert T. On the optimal temporal resolution for phase contrast cardiovascular magnetic resonance imaging: establishment of baseline values. J Cardiovasc Magn Reson. 2020 Oct 5;22(1):72. doi: 10.1186/s12968-020-00669-1.
A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.

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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 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sacubitril/valsartan (LCZ696), olmesartan and Amlodipine (Optional) in people with Hypertension, run by Novartis Pharmaceuticals at 4 sites in 3 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 1 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 5 Jan 2021. 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 Germany, Switzerland, United Kingdom. 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 1 Sep 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 Ascending Aorta Distensibility at 52 Week (time frame: Baseline, 52 weeks). The study lists 3 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 NCT01870739, which also lists 2 linked publications.

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 5 Jan 2021.