Essential HypertensionPhase 3NCT01599104
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
A Phase 3 study testing LCZ696 and Olmesartan in people with Essential Hypertension, run by Novartis Pharmaceuticals at 61 sites in Japan.
Trial summary
This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension Read more about this study
- Who is it for?
- Ages 20 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
- 1,161 participants
- Where
- 61 sitesJapan
- Study dates
- Jun 2012to Apr 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 20 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 proceeding 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
- 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
61 sites in 1 country.
61 sites in 1 country
Japan61 sites
Novartis Investigative Site
Ageo, Saitama, 362-8588
Novartis Investigative Site
Amagasaki, Hyōgo, 660-0814
Novartis Investigative Site
Asahikawa, Hokkaido, 078-8214
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655
Novartis Investigative Site
Chikushi-gun, Fukuoka, 811-1244
Novartis Investigative Site
Chiyoda-ku, Tokyo, 100-0005
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, 810-0014
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0066
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukuoka, Fukuoka, 814-0032
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
Hitachi, Ibaraki, 317-0077
Novartis Investigative Site
Ibadraki, Osaka, 567-0876
Novartis Investigative Site
Kamogawa, Chiba, 296-8602
Novartis Investigative Site
Kashihara, Nara, 634-8522
Novartis Investigative Site
Katsushika-ku, Tokyo, 124-0024
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0225
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, 615-0035
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
Nerima-ku, Tokyo, 177-0051
Novartis Investigative Site
Niiza, Saitama, 352-0014
Novartis Investigative Site
Osaka, Osaka, 536-0008
Novartis Investigative Site
Osaka, Osaka, 547-0013
Novartis Investigative Site
Osaka, Osaka, 550-0013
Novartis Investigative Site
Osaka, Osaka, 560-0005
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Saitama, Saitama, 337-0012
Novartis Investigative Site
Sakado, Saitama, 350-0202
Novartis Investigative Site
Sapporo, Hokkaido, 003-0026
Novartis Investigative Site
Sapporo, Hokkaido, 003-0825
Novartis Investigative Site
Sapporo, Hokkaido, 006-0811
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
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0053
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0063
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
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
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Toyonaka, Osaka, 560-0082
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023
Novartis Investigative Site
Yokohama, Kanagawa, 236-0004
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 Japanese Patients With Essential Hypertension
This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension
- Conditions
- Essential Hypertension
- Being tested
- LCZ696, Olmesartan, Placebo
- 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
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
OlmesartanDrug
Olmesartan 20 mg capsule one daily
PlaceboDrug
Placebo to LCZ696 or Olmesartan
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 200 mg | Experimental | LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks Receives: Drug: LCZ696; Drug: Placebo |
| LCZ696 400 mg | Experimental | LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks Receives: Drug: LCZ696; Drug: Placebo |
| Olmesartan 20 mg | Active comparator | Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks 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 screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Measured: Baseline, 8 weeks
Secondary outcomes (10)
Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Measured: Baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
Measured: Baseline, 8 weeks
Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
Measured: 8 weeks
Percentage of Participants Achieving a Successful msSBP Response
Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.
Measured: 8 weeks
Percentage of Participants Achieving a Successful msDBP Response
Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.
Measured: 8 weeks
Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Measured: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP for Daytime/Nighttime
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Measured: Baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.
Measured: Baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.
Measured: Baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events and Death
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,161 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
- NCT01599104
- Sponsor's protocol ID
- CLCZ696A1306
- Status last verified
- Sep 2015
- First submitted
- 13 May 2012
- Last updated
- 16 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kario K, Rakugi H, Yarimizu D, Morita Y, Eguchi S, Iekushi K. Twenty-Four-Hour Blood Pressure-Lowering Efficacy of Sacubitril/Valsartan Versus Olmesartan in Japanese Patients With Essential Hypertension Based on Nocturnal Blood Pressure Dipping Status: A Post Hoc Analysis of Data From a Randomized, Double-Blind Multicenter Study. J Am Heart Assoc. 2023 Apr 18;12(8):e027612. doi: 10.1161/JAHA.122.027612. Epub 2023 Apr 7.
PubMed 37026551
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. 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 Japanese Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01599104
- Acronym / sponsor ID
- CLCZ696A1306
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, LCZ696
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,161 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 6 Aug 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 assessed the efficacy of LCZ696 in Japanese patients with essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LCZ696 200 mg | Experimental | Drug: LCZ696, Drug: PlaceboLCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks |
| LCZ696 400 mg | Experimental | Drug: LCZ696, Drug: PlaceboLCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks |
| Olmesartan 20 mg | Active comparator | Drug: Olmesartan, Drug: PlaceboOlmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks |
Who may qualify
- Ages
- 20 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 proceeding 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)
- 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 |
|---|---|---|
| LCZ696200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily | Drug | LCZ696 200 mg, LCZ696 400 mg |
| OlmesartanOlmesartan 20 mg capsule one daily | Drug | Olmesartan 20 mg |
| PlaceboPlacebo to LCZ696 or Olmesartan | Drug | LCZ696 200 mg, LCZ696 400 mg, Olmesartan 20 mg |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, 8 weeks
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.
10 secondary outcomes
Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, 8 weeks
Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
Time frame: 8 weeks
Percentage of Participants Achieving a Successful msSBP Response
Time frame: 8 weeks
Percentage of Participants Achieving a Successful msDBP Response
Time frame: 8 weeks
Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP for Daytime/Nighttime
Time frame: Baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Time frame: Baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Time frame: Baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events and Death
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37026551Kario K, Rakugi H, Yarimizu D, Morita Y, Eguchi S, Iekushi K. Twenty-Four-Hour Blood Pressure-Lowering Efficacy of Sacubitril/Valsartan Versus Olmesartan in Japanese Patients With Essential Hypertension Based on Nocturnal Blood Pressure Dipping Status: A Post Hoc Analysis of Data From a Randomized, Double-Blind Multicenter Study. J Am Heart Assoc. 2023 Apr 18;12(8):e027612. doi: 10.1161/JAHA.122.027612. Epub 2023 Apr 7.
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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
61 sites in 1 country: 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 61 sites in Japan.
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 16 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 61 sites in Japan. 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 6 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, 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 NCT01599104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.