Essential HypertensionPhase 3NCT01615198
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
A Phase 3 study testing Olmesartan and LCZ696 in people with Essential Hypertension, run by Novartis Pharmaceuticals at 79 sites in 7 countries.
Trial summary
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Olmesartan and LCZ696
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 79 sitesin 7 countries
- Study dates
- Aug 2012to Jul 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must give written informed consent before any assessment is performed
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
- Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Who cannot join
- Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
- Patients with history or evidence of a secondary form of 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.
- Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
- Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
Show all 9Show fewer
- Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
- Patients with a clinically significant valvular heart disease at the time of screening
- Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
79 sites in 7 countries.
79 sites in 7 countries
Japan35 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8214
Novartis Investigative Site
Chikushi-gun, Fukuoka, 811-1244
Novartis Investigative Site
Edogawa-ku, Tokyo, 133-0061
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0084
Novartis Investigative Site
Fujimino, Saitama, 356-0053
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0066
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046
Novartis Investigative Site
Hachiōji, Tokyo, 192-0918
Novartis Investigative Site
Hiki-Gun, Saitama, 355-0328
Novartis Investigative Site
Katsushika-ku, Tokyo, 124-0024
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-0856
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Koshigaya, Saitama, 343-0826
Novartis Investigative Site
Kunitachi, Tokyo, 186-0001
Novartis Investigative Site
Kyōtanabe, Kyoto, 610-0361
Novartis Investigative Site
Kyoto, Kyoto, 615-8125
Novartis Investigative Site
Meguro-ku, Tokyo, 152-0031
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Osaka, Osaka, 560-0005
Novartis Investigative Site
Saitama, Saitama, 337-0012
Novartis Investigative Site
Sapporo, Hokkaido, 003-0026
Novartis Investigative Site
Sapporo, Hokkaido, 003-0825
Novartis Investigative Site
Sapporo, Hokkaido, 062-0053
Novartis Investigative Site
Sapporo, Hokkaido, 063-0842
Novartis Investigative Site
Shibuya-ku, Tokyo, 150-0002
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Suita, Osaka, 565-0871
Novartis Investigative Site
Tachikawa, Tokyo, 190-0013
Novartis Investigative Site
Taitō City, Tokyo, 111-0052
Novartis Investigative Site
Tokorozawa, Saitama, 359-1161
Novartis Investigative Site
Tōon, Ehime, 791-0295
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Toyonaka, Osaka, 560-0082
South Korea15 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 424-717
Novartis Investigative Site
Daegu, 700-712
Novartis Investigative Site
Daejeon, 302-241
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 412-270
Novartis Investigative Site
Incheon, 22332
Novartis Investigative Site
Incheon, 403-720
Novartis Investigative Site
Jeonju, Jeollabuk-do, 561-712
Novartis Investigative Site
Koyang, Kyunggi, 410-719
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-707
Novartis Investigative Site
Seoul, Seoul, 150-713
Novartis Investigative Site
Seoul, 100-380
Novartis Investigative Site
Seoul, 134-727
Novartis Investigative Site
Seoul, 135-720
Novartis Investigative Site
Seoul, 150-950
Novartis Investigative Site
Seoul, 152-703
China10 sites
Novartis Investigative Site
Beijing, 100020
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400042
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310013
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Tianjin, 300142
Novartis Investigative Site
Xi’an, Shanxi, 710061
Taiwan8 sites
Novartis Investigative Site
Changhua, 500
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan, ROC, 112
Novartis Investigative Site
Taipei
Philippines5 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
Novartis Investigative Site
Valenzuela, 1441
Hong Kong3 sites
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong, Shatin, NT
Novartis Investigative Site
Hong Kong
Thailand3 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
About this study
Official title: A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
- Conditions
- Essential Hypertension
- Being tested
- Olmesartan, Placebo, LCZ696
- Keywords
- Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlmesartanDrug
10 mg, 20 mg, 40 mg capsules
PlaceboDrug
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
LCZ696Drug
100 mg, 200 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 | Experimental | Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. Receives: Drug: Placebo; Drug: LCZ696 |
| Olmesartan | Active comparator | Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd. Receives: Drug: Olmesartan; Drug: Placebo |
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)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Secondary outcomes (11)
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.
Measured: Baseline, 4 weeks, 14 weeks
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
Measured: Baseline, 4 weeks, 10 weeks, 14 weeks
Change From Baseline in Daytime and Nighttime maSBP/maDBP
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Measured: Baseline, 10 weeks
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
Measured: 4 weeks, 10 weeks, 14 weeks
Number of Participants Achieving Successful Response in msSBP and msDBP
Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.
Measured: 4 weeks,10 weeks, 14 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse event monitoring was conducted throughout the study.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 588 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
- NCT01615198
- Sponsor's protocol ID
- CLCZ696A2316
- Status last verified
- Oct 2015
- First submitted
- 6 Jun 2012
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01615198
- Acronym / sponsor ID
- CLCZ696A2316
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Posted 18 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 | Experimental | Drug: Placebo, Drug: LCZ696Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. |
| Olmesartan | Active comparator | Drug: Olmesartan, Drug: PlaceboParticipants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients must give written informed consent before any assessment is performed
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
- Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Key exclusion criteria (9 listed)
- Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
- Patients with history or evidence of a secondary form of 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.
- Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
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 |
|---|---|---|
| Olmesartan10 mg, 20 mg, 40 mg capsules | Drug | Olmesartan |
| PlaceboMatching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule | Drug | LCZ696, Olmesartan |
| LCZ696100 mg, 200 mg tablets | Drug | LCZ696 |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, 10 weeks
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
11 secondary outcomes
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, 4 weeks, 14 weeks
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, 10 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Time frame: Baseline, 4 weeks, 10 weeks, 14 weeks
Change From Baseline in Daytime and Nighttime maSBP/maDBP
Time frame: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
Time frame: Baseline, 10 weeks
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
Time frame: Baseline, 10 weeks
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: 4 weeks, 10 weeks, 14 weeks
Number of Participants Achieving Successful Response in msSBP and msDBP
Time frame: 4 weeks,10 weeks, 14 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- 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
79 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 Olmesartan and LCZ696 in people with Essential Hypertension, run by Novartis Pharmaceuticals at 79 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 3 inclusion and 9 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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Japan, South Korea, China, Taiwan, 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 18 Aug 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) (time frame: Baseline, 10 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 23 Oct 2015.