Essential HypertensionPhase 3NCT01785472
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
A Phase 3 study testing LCZ696 and Olmesartan in people with Essential Hypertension, run by Novartis Pharmaceuticals at 50 sites in 7 countries.
Trial summary
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential 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
- 1,438 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Apr 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 treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
- Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit 201.
- Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
Who cannot join
- Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
- History of angioedema, drug-related or otherwise, as reported by the patient.
- 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.
- Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
China28 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100044
Novartis Investigative Site
Beijing, 100020
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400042
Novartis Investigative Site
Fuzhou, Fujian
Novartis Investigative Site
Fuzhou, 350001
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Hangzhou, Zhejiang, 310013
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Nanning, Guangxi, 530021
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200072
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200120
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200031
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Shenyang, Liaoning, 110016
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Tianjin, 300142
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Xi’an, Shanxi, 710004
Novartis Investigative Site
Xi’an, Shanxi, 710061
Taiwan9 sites
Novartis Investigative Site
Douliu, 640
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Kaohsiung City, 82445
Novartis Investigative Site
New Taipei City, 23561
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Tainan, Taiwan ROC, 70403
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, 110
Novartis Investigative Site
Taipei County, Taiwan, 22060
South Korea5 sites
Novartis Investigative Site
Koyang, Kyunggi, 410-719
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06591
Novartis Investigative Site
Seoul, Korea, 08308
Thailand4 sites
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Khon Kaen, THA, 40002
Novartis Investigative Site
Rajathevee, Thailand, 10400
Philippines2 sites
Novartis Investigative Site
Quezon City, Manila, 1100
Novartis Investigative Site
Quezon City, 1102
About this study
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension
- Conditions
- Essential Hypertension
- Being tested
- LCZ696, Olmesartan, Placebo of LCZ696, Placebo of Olmesartan
- Keywords
- Essential hypertension, LCZ696
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
LCZ696 200 mg tablet
OlmesartanDrug
Olmesartan 20 mg capsule
Placebo of LCZ696Drug
Placebo tablet of LCZ696 200 mg once daily
Placebo of OlmesartanDrug
Placebo capsule of olmesartan 20 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 200 mg | Experimental | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. Receives: Drug: LCZ696; Drug: Placebo of LCZ696; Drug: Placebo of Olmesartan |
| LCZ696 400 mg | Experimental | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. Receives: Drug: LCZ696; Drug: Placebo of LCZ696; Drug: Placebo of Olmesartan |
| Olmesartan 20 mg | Active comparator | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. Receives: Drug: Olmesartan; Drug: Placebo of LCZ696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
Measured: baseline, 8 weeks
Secondary outcomes (12)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements
Measured: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement
Measured: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure (msPP)
Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.
Measured: baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.
Measured: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Measured: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Measured: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Measured: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
Measured: baseline, 8 weeks
Number of Patients Achieving Successful Blood Pressure Control
Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.
Measured: 8 weeks
Change From Baseline in Ambulatory Pulse Pressure
Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.
Measured: baseline, 8 weeks
Number of Responders
Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)
Measured: baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startApr 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 Essential 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
- 1,438 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
- NCT01785472
- Sponsor's protocol ID
- CLCZ696A2315
- Other IDs
- CLCZ696A2315
- Status last verified
- Nov 2016
- First submitted
- 5 Feb 2013
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01785472
- Acronym / sponsor ID
- CLCZ696A2315
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, LCZ696
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,438 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 4 Sep 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 multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LCZ696 200 mg | Experimental | Drug: LCZ696, Drug: Placebo of LCZ696, Drug: Placebo of OlmesartanPatients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. |
| LCZ696 400 mg | Experimental | Drug: LCZ696, Drug: Placebo of LCZ696, Drug: Placebo of OlmesartanPatients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. |
| Olmesartan 20 mg | Active comparator | Drug: Olmesartan, Drug: Placebo of LCZ696Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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 treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
- Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit 201.
- Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
Key exclusion criteria (5 listed)
- Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
- History of angioedema, drug-related or otherwise, as reported by the patient.
- 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.
- Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| LCZ696LCZ696 200 mg tablet | Drug | LCZ696 200 mg, LCZ696 400 mg |
| OlmesartanOlmesartan 20 mg capsule | Drug | Olmesartan 20 mg |
| Placebo of LCZ696Placebo tablet of LCZ696 200 mg once daily | Drug | LCZ696 200 mg, LCZ696 400 mg, Olmesartan 20 mg |
| Placebo of OlmesartanPlacebo capsule of olmesartan 20 mg once daily | Drug | LCZ696 200 mg, LCZ696 400 mg |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg
Time frame: baseline, 8 weeks
Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
12 secondary outcomes
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg
Time frame: baseline, 8 weeks
Change From Baseline in Office Pulse Pressure (msPP)
Time frame: baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Blood Pressure
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.
Time frame: baseline, 8 weeks
Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.
Time frame: baseline, 8 weeks
Number of Patients Achieving Successful Blood Pressure Control
Time frame: 8 weeks
Change From Baseline in Ambulatory Pulse Pressure
Time frame: baseline, 8 weeks
Number of Responders
Time frame: baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability
Time frame: baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- 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
50 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 Essential Hypertension, run by Novartis Pharmaceuticals at 50 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 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China, Taiwan, South Korea, Thailand, 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 4 Sep 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 Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg (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?
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 29 Dec 2016.