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

September 25, 2015 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 814-0032
        • Novartis Investigative Site
      • Osaka, Japan, 536-0008
        • Novartis Investigative Site
      • Osaka, Japan, 550-0013
        • Novartis Investigative Site
      • Osaka, Japan, 560-0005
        • Novartis Investigative Site
      • Saitama, Japan, 337-0012
        • Novartis Investigative Site
    • Chiba
      • Kamogawa-City, Chiba, Japan, 296-8602
        • Novartis Investigative Site
    • Fukuoka
      • Chikushi-gun, Fukuoka, Japan, 811-1244
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japan, 810-0014
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japan, 810-0066
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 800-0225
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 807-0856
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8214
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 003-0026
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 003-0825
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 006-0811
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 062-0053
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 063-0842
        • Novartis Investigative Site
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-0814
        • Novartis Investigative Site
    • Ibaraki
      • Hitachi-city, Ibaraki, Japan, 317-0077
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 231-0023
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
    • Kyoto
      • Kyotanabe-city, Kyoto, Japan, 610-0361
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 615-0035
        • Novartis Investigative Site
      • Kyoto-city, Kyoto, Japan, 615-8125
        • Novartis Investigative Site
    • Nara
      • Kashihara-city, Nara, Japan, 634-8522
        • Novartis Investigative Site
    • Osaka
      • Ibadraki, Osaka, Japan, 567-0876
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 547-0013
        • Novartis Investigative Site
      • Toyonaka-city, Osaka, Japan, 560-0082
        • Novartis Investigative Site
    • Saitama
      • Ageo-city, Saitama, Japan, 362-8588
        • Novartis Investigative Site
      • Fujimino, Saitama, Japan, 356-0053
        • Novartis Investigative Site
      • Hiki-Gun, Saitama, Japan, 355-0328
        • Novartis Investigative Site
      • Koshigaya city, Saitama, Japan, 343-0826
        • Novartis Investigative Site
      • Niiza-city, Saitama, Japan, 352-0014
        • Novartis Investigative Site
      • Sakado, Saitama, Japan, 350-0202
        • Novartis Investigative Site
      • Tokorozawa-city, Saitama, Japan, 359-1161
        • Novartis Investigative Site
    • Tochigi
      • Shimotsuke-city, Tochigi, Japan, 329-0498
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0031
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 100-0005
        • Novartis Investigative Site
      • Edogawa-ku, Tokyo, Japan, 133-0061
        • Novartis Investigative Site
      • Edogawa-ku, Tokyo, Japan, 134-0084
        • Novartis Investigative Site
      • Hachioji, Tokyo, Japan, 192-0046
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 192-0918
        • Novartis Investigative Site
      • Katsushika-ku, Tokyo, Japan, 124-0024
        • Novartis Investigative Site
      • Kiyose-city, Tokyo, Japan, 204-0021
        • Novartis Investigative Site
      • Kunitachi, Tokyo, Japan, 186-0001
        • Novartis Investigative Site
      • Meguro-ku, Tokyo, Japan, 152-0031
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-7390
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 108-0075
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 177-0051
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Shibuya-ku, Tokyo, Japan, 150-0002
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 141-0032
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-0053
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-0063
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Novartis Investigative Site
      • Tachikawa, Tokyo, Japan, 190-0013
        • Novartis Investigative Site
      • Taito, Tokyo, Japan, 111-0052
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LCZ696 200 mg
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
Drug: LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Drug: Placebo
Placebo to LCZ696 or Olmesartan
Experimental: LCZ696 400 mg
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
Drug: LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Drug: Placebo
Placebo to LCZ696 or Olmesartan
Active Comparator: Olmesartan 20 mg
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
Drug: Placebo
Placebo to LCZ696 or Olmesartan
Drug: Olmesartan
Olmesartan 20 mg capsule one daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8
Time Frame: Baseline, 8 weeks
Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8
Time Frame: 8 weeks
A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.
8 weeks
Percentage of Participants Achieving a Successful msSBP Response
Time Frame: 8 weeks
Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.
8 weeks
Percentage of Participants Achieving a Successful msDBP Response
Time Frame: 8 weeks
Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.
8 weeks
Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8
Time Frame: Baseline, 8 weeks
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Baseline, 8 weeks
Change From Baseline in maSBP and maDBP for Daytime/Nighttime
Time Frame: Baseline, 8 weeks
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.
Baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure
Time Frame: Baseline, 8 weeks
Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.
Baseline, 8 weeks
Number of Patients With Adverse Events, Serious Adverse Events and Death
Time Frame: 8 weeks
Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLCZ696A1306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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