Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

November 3, 2015 updated by: Novartis Pharmaceuticals

A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

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.
376

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

  • Argentina
      • Buenos aires, Argentina, C1120AAC
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1429BWN
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1119ACN
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1430AAQ
        • Novartis Investigative Site
    • Capital Federal
      • Caba, Capital Federal, Argentina, C1425FVH
        • Novartis Investigative Site
    • Misiones
      • Posadas, Misiones, Argentina, N3300AHX
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01001
        • Novartis Investigative Site
  • Philippines
      • Quezon City, Philippines, 1102
        • Novartis Investigative Site
      • Quezon City, Philippines, 1100
        • Novartis Investigative Site
    • Manila
      • Quezon City, Manila, Philippines, 1100
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1000
        • Novartis Investigative Site
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novartis Investigative Site
      • Ponce, Puerto Rico, 00717
        • Novartis Investigative Site
      • Ponce, Puerto Rico, 00716
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 117198
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129301
        • Novartis Investigative Site
      • Moscow, Russian Federation, 101990
        • Novartis Investigative Site
      • Moscow, Russian Federation, 111539
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 199106
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410012
        • Novartis Investigative Site
      • St.- Petersburg, Russian Federation, 197110
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Cataluña
      • Centelles, Cataluña, Spain, 08540
        • Novartis Investigative Site
      • Hostalets de Balenya, Cataluña, Spain, 08550
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alzira, Comunidad Valenciana, Spain, 46600
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2041
        • Novartis Investigative Site
    • California
      • Fair Oaks, California, United States, 95628
        • Novartis Investigative Site
      • Hawaiian Gardens, California, United States, 90716
        • Novartis Investigative Site
      • Long Beach, California, United States, 90806
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90057
        • Novartis Investigative Site
      • Orangevale, California, United States, 95662
        • Novartis Investigative Site
      • Westlake Village, California, United States, 91361
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Novartis Investigative Site
      • Conyers, Georgia, United States, 30094
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novartis Investigative Site
      • Chicago, Illinois, United States, 60610
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Novartis Investigative Site
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10708
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Novartis Investigative Site
    • Oregon
      • Oregon City, Oregon, United States, 97045
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97225
        • Novartis Investigative Site
    • South Carolina
      • Varnville, South Carolina, United States, 29944
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • 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

18 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 drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
  • untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
  • patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion Criteria:

  • Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  • History of angioedema, drug-related or otherwise
  • 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 (PKD), drug-induced hypertension
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

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: Double

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
Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
Drug: Placebo of LCZ696
Drug: LCZ696
Active Comparator: Olmesartan 20 mg
Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Drug: Placebo of Olmesartan
Drug: Olmesartan

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 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)
Time Frame: baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
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 Diastolic Blood Pressure (maDBP)
Time Frame: baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
baseline, 8 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: baseline, 8 weeks
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: baseline, 8 weeks
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
baseline, 8 weeks
Change From Baseline in Office Pulse Pressure
Time Frame: baseline, 8 weeks
Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
baseline, 8 weeks
Number of Patients Achieving Successful Overall Blood Pressure Control
Time Frame: 8 weeks
Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg
8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control
Time Frame: 8 weeks
Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg
8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control
Time Frame: 8 weeks
Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg
8 weeks
Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response
Time Frame: baseline, 8 weeks
Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
baseline, 8 weeks
Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response
Time Frame: baseline, 8 weeks
Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.
baseline, 8 weeks
Number of Patients With Total Adverse Events, Serious Adverse Events and Death
Time Frame: 8 weeks
Number of patients with total adverse events, serious adverse events and death were reported.
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.
September 1, 2013

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.
August 1, 2014

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.
August 1, 2014

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).
June 9, 2013

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.
June 9, 2013

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.
June 12, 2013

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.
December 7, 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.
November 3, 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.
November 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.
  • CLCZ696A2318
  • 2013-001783-36 (EudraCT Number)

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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