HypertensionPhase 3NCT01876368

Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

A Phase 3 study testing LCZ696 and Olmesartan in people with Hypertension, run by Novartis Pharmaceuticals at 51 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: LCZ696 and Olmesartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 376 participants
Where: 51 sitesin 7 countries
Study dates: Sep 2013to Aug 2014
Phase: Phase 3
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

patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

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 (PKD), drug-induced hypertension
Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Trial locations and contacts

51 sites in 7 countries.

Country

City, postcode or hospital

51 sites in 7 countries

United States22 sites

Novartis Investigative Site
Atlanta, Georgia, 30308
Novartis Investigative Site
Belzoni, Mississippi, 39038
Novartis Investigative Site
Birmingham, Alabama, 35294-2041
Novartis Investigative Site
Chicago, Illinois, 60607
Novartis Investigative Site
Chicago, Illinois, 60610
Novartis Investigative Site
Cincinnati, Ohio, 45246
Novartis Investigative Site
Conyers, Georgia, 30094
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Edina, Minnesota, 55435
Novartis Investigative Site
Fair Oaks, California, 95628
Novartis Investigative Site
Hawaiian Gardens, California, 90716
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Long Beach, California, 90806
Novartis Investigative Site
Los Angeles, California, 90057
Novartis Investigative Site
New York, New York, 10708
Novartis Investigative Site
Orangevale, California, 95662
Novartis Investigative Site
Oregon City, Oregon, 97045
Novartis Investigative Site
Portland, Oregon, 97225
Novartis Investigative Site
Richmond, Virginia, 23294
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Varnville, South Carolina, 29944
Novartis Investigative Site
Westlake Village, California, 91361

Other trials in United States

Argentina7 sites

Novartis Investigative Site
Buenos Aires, Buenos Aires, C1120AAC
Novartis Investigative Site
Caba, Buenos Aires, C1429BWN
Novartis Investigative Site
Caba, Buenos Aires F.D., C1425FVH
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1430AAQ
Novartis Investigative Site
Corrientes, Corrientes Province, W3400
Novartis Investigative Site
Posadas, Misiones Province, N3300AHX

Other trials in Argentina

Russia7 sites

Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 111539
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 129301
Novartis Investigative Site
Saint Petersburg, 197110
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Saratov, 410012

Other trials in Russia

Spain6 sites

Novartis Investigative Site
Alzira, Valencia, 46600
Novartis Investigative Site
Centelles, Catalonia, 08540
Novartis Investigative Site
Hostalets de Balenya, Catalonia, 08550
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41009

Other trials in Spain

Philippines4 sites

Novartis Investigative Site
Manila, National Capital Region, 1000
Novartis Investigative Site
Quezon City, Manila, 1100
Novartis Investigative Site
Quezon City, 1100
Novartis Investigative Site
Quezon City, 1102

Other trials in Philippines

Puerto Rico3 sites

Novartis Investigative Site
Manati, 00674
Novartis Investigative Site
Ponce, 00716
Novartis Investigative Site
Ponce, 00717

Other trials in Puerto Rico

Guatemala2 sites

Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01001
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010

Other trials in Guatemala

About this study

Official title: A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Conditions: Hypertension
Being tested: LCZ696, Olmesartan, Placebo of LCZ696, Placebo of Olmesartan
Keywords: hypertension,, LCZ696,, olmesartan
Medical subject headings: Hypertension

What participants receive

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

LCZ696Drug
OlmesartanDrug
Placebo of LCZ696Drug
Placebo of OlmesartanDrug

Study groups in NCT01876368
Study group	Role	What they receive
LCZ696 200 mg	Experimental	Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. Receives: Drug: LCZ696; Drug: Placebo of LCZ696
Olmesartan 20 mg	Active comparator	Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. Receives: Drug: Olmesartan; Drug: Placebo of Olmesartan

What is being measured

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

Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
Measured: baseline, 8 weeks

Secondary outcomes (10)

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
Measured: baseline, 8 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Measured: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
Measured: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
Measured: baseline, 8 weeks
Number of Patients Achieving Successful Overall Blood Pressure Control
Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
Measured: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
Measured: 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
Measured: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
Measured: baseline, 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.
Measured: baseline, 8 weeks
Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Number of patients with total adverse events, serious adverse events and death were reported.
Measured: 8 weeks

Timeline

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

Sep 2013Aug 2014

First posted12 Jun 2013 (estimated)
Study startSep 2013
Primary completionAug 2014
Study completionAug 2014

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01876368
Sponsor's protocol ID: CLCZ696A2318
Other IDs: 2013-001783-36
Status last verified: Nov 2015
First submitted: 9 Jun 2013
Last updated: 7 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan
ClinicalTrials.gov ID: NCT01876368
Acronym / sponsor ID: CLCZ696A2318
Conditions: Hypertension
Keywords: hypertension,, LCZ696,, olmesartan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 12 Jun 2013 (estimated)
Results: Posted 7 Dec 2015

Clinical summary

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

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LCZ696 200 mg	Experimental	Drug: LCZ696, Drug: Placebo of LCZ696Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Olmesartan 20 mg	Active comparator	Drug: Olmesartan, Drug: Placebo of OlmesartanPatients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Key exclusion criteria (4 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 (PKD), drug-induced hypertension
Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

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
LCZ696	Drug	LCZ696 200 mg
Olmesartan	Drug	Olmesartan 20 mg
Placebo of LCZ696	Drug	LCZ696 200 mg
Placebo of Olmesartan	Drug	Olmesartan 20 mg

Primary outcome

Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Time frame: baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.

10 secondary outcomes

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Time frame: baseline, 8 weeks
Number of Patients Achieving Successful Overall Blood Pressure Control
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Time frame: 8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Time frame: baseline, 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Time frame: baseline, 8 weeks
Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Time frame: 8 weeks

Results and safety

Results posted to the registry on 7 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCZ696 200 mg	188	179
Olmesartan 20 mg	188	175

Primary outcome: Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)

Time frame: baseline, 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	LCZ696 200 mg n = 167	Olmesartan 20 mg n = 164
Value	-4.26 (0.60)	-1.04 (0.61)

LCZ696 200 mg vs Olmesartan 20 mg: Mean Difference (Net): -3.19 (95% CI -4.73 to -1.65), p <0.001, ANCOVA

Population analysed: A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCZ696 200 mg	0 of 188 (0%)	7 of 188 (3.7%)	Not reported
Olmesartan 20 mg	2 of 187 (1.1%)	10 of 187 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Chronic Kidney Disease, Hypertension (HTN)
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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

51 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LCZ696 and Olmesartan in people with Hypertension, run by Novartis Pharmaceuticals at 51 sites in 7 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 4 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Argentina, Russia, Spain, Philippines and 2 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 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?

Yes. Results are posted in the registry (first posted 7 Dec 2015). 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 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) (time frame: baseline, 8 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 NCT01876368.

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 Dec 2015.