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A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LCZ696

Amlodipine

Hydrochlorothiazide (HCTZ)

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor, angiotensin receptor neprilysin inhibitor (ARNi)

Eligibility Criteria

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

Inclusion Criteria:

Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion Criteria:

Patients who did not complete CLCZ696A2219.
Presence of significant protocol violation in CLCZ696A2219.
Patients who are deemed to be unable to comply with the protocol by the investigator.
Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LCZ696

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

Secondary Outcome Measures

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

Blood pressure (BP) control is defined as BP <140/90 mmHg.

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

Blood pressure (BP) control is defined as BP <140/90 mmHg.

Full Information

NCT ID

NCT01256411

First Posted

December 7, 2010

Last Updated

September 22, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01256411

Brief Title

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Official Title

An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor, angiotensin receptor neprilysin inhibitor (ARNi)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LCZ696

Intervention Description

Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Intervention Description

Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide (HCTZ)

Intervention Description

Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

Description

Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

Time Frame

Baseline to 12 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

Description

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Time Frame

Baseline, 12 months

Title

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

Description

Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

Time Frame

Baseline, 12 months

Title

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

Description

Blood pressure (BP) control is defined as BP <140/90 mmHg.

Time Frame

Baseline to 12 months

Title

Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

Description

Blood pressure (BP) control is defined as BP <140/90 mmHg.

Time Frame

Baseline to 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study. Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219. Exclusion Criteria: Patients who did not complete CLCZ696A2219. Presence of significant protocol violation in CLCZ696A2219. Patients who are deemed to be unable to comply with the protocol by the investigator. 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

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300142

Country

China

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

231-0023

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

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

100-0005

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

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

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

143-0023

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

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Bucheon

State/Province

Gyeonggi-do

ZIP/Postal Code

424-717

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Koyang

State/Province

Kyunggi

ZIP/Postal Code

410-719

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Daegu

ZIP/Postal Code

705-703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

150-950

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

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A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Essential Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial