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Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
LCZ696
Olmesartan
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension, LCZ696

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LCZ696 200 mg

LCZ696 400 mg

Olmesartan 20 mg

Arm Description

LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks

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

Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Percentage of Participants Achieving a Successful msSBP Response
Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.
Percentage of Participants Achieving a Successful msDBP Response
Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.
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.
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.
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.
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.
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.

Full Information

First Posted
May 13, 2012
Last Updated
September 25, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01599104
Brief Title
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension, LCZ696

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCZ696 200 mg
Arm Type
Experimental
Arm Description
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
Arm Title
LCZ696 400 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Olmesartan 20 mg
Arm Type
Active Comparator
Arm Description
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
LCZ696
Intervention Description
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Intervention Type
Drug
Intervention Name(s)
Olmesartan
Intervention Description
Olmesartan 20 mg capsule one daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to LCZ696 or Olmesartan
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Description
Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame
Baseline, 8 weeks
Title
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Description
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.
Time Frame
Baseline, 8 weeks
Title
Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
Description
A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
Time Frame
8 weeks
Title
Percentage of Participants Achieving a Successful msSBP Response
Description
Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.
Time Frame
8 weeks
Title
Percentage of Participants Achieving a Successful msDBP Response
Description
Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.
Time Frame
8 weeks
Title
Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
Description
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame
Baseline, 8 weeks
Title
Change From Baseline in maSBP and maDBP for Daytime/Nighttime
Description
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Time Frame
Baseline, 8 weeks
Title
Change From Baseline in Office Pulse Pressure
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Description
Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.
Time Frame
Baseline, 8 weeks
Title
Number of Patients With Adverse Events, Serious Adverse Events and Death
Description
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Kamogawa-City
State/Province
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Chikushi-gun
State/Province
Fukuoka
ZIP/Postal Code
811-1244
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
810-0014
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
810-0066
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitakyushu-city
State/Province
Fukuoka
ZIP/Postal Code
800-0225
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitakyushu-city
State/Province
Fukuoka
ZIP/Postal Code
807-0856
Country
Japan
Facility Name
Novartis Investigative Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8214
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
006-0811
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
062-0053
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
063-0842
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0825
Country
Japan
Facility Name
Novartis Investigative Site
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-0814
Country
Japan
Facility Name
Novartis Investigative Site
City
Hitachi-city
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki-city
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyotanabe-city
State/Province
Kyoto
ZIP/Postal Code
610-0361
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
615-0035
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
615-8125
Country
Japan
Facility Name
Novartis Investigative Site
City
Kashihara-city
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Novartis Investigative Site
City
Ibadraki
State/Province
Osaka
ZIP/Postal Code
567-0876
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
547-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyonaka-city
State/Province
Osaka
ZIP/Postal Code
560-0082
Country
Japan
Facility Name
Novartis Investigative Site
City
Ageo-city
State/Province
Saitama
ZIP/Postal Code
362-8588
Country
Japan
Facility Name
Novartis Investigative Site
City
Fujimino
State/Province
Saitama
ZIP/Postal Code
356-0053
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiki-Gun
State/Province
Saitama
ZIP/Postal Code
355-0328
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshigaya city
State/Province
Saitama
ZIP/Postal Code
343-0826
Country
Japan
Facility Name
Novartis Investigative Site
City
Niiza-city
State/Province
Saitama
ZIP/Postal Code
352-0014
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakado
State/Province
Saitama
ZIP/Postal Code
350-0202
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokorozawa-city
State/Province
Saitama
ZIP/Postal Code
359-1161
Country
Japan
Facility Name
Novartis Investigative Site
City
Shimotsuke-city
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0031
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Novartis Investigative Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
100-0005
Country
Japan
Facility Name
Novartis Investigative Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0061
Country
Japan
Facility Name
Novartis Investigative Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
134-0084
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji-city
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Novartis Investigative Site
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
124-0024
Country
Japan
Facility Name
Novartis Investigative Site
City
Kiyose-city
State/Province
Tokyo
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Novartis Investigative Site
City
Kunitachi
State/Province
Tokyo
ZIP/Postal Code
186-0001
Country
Japan
Facility Name
Novartis Investigative Site
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-0031
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-7390
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Novartis Investigative Site
City
Nerima-ku
State/Province
Tokyo
ZIP/Postal Code
177-0051
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-0002
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-0053
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-0063
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Taito
State/Province
Tokyo
ZIP/Postal Code
111-0052
Country
Japan
Facility Name
Novartis Investigative Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
814-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
536-0008
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
550-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
560-0005
Country
Japan
Facility Name
Novartis Investigative Site
City
Saitama
ZIP/Postal Code
337-0012
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

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