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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01256411
First received: December 7, 2010
Last updated: September 22, 2015
Last verified: September 2015
  Purpose
The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Condition Intervention Phase
Essential Hypertension
Drug: LCZ696
Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Blood pressure (BP) control is defined as BP <140/90 mmHg.


Enrollment: 341
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCZ696 Drug: LCZ696
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.
Drug: Amlodipine
Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
Drug: Hydrochlorothiazide (HCTZ)
Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256411

Locations
China, Chongqing
Novartis Investigative Site
Chongqing, Chongqing, China, 400042
China, Hebei
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310006
China
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Beijing, China, 100044
Novartis Investigative Site
Tianjin, China, 300142
Japan
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 231-0023
Novartis Investigative Site
Shimotsuke-city, Tochigi, Japan, 329-0498
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-0031
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan, 100-0005
Novartis Investigative Site
Kiyose-city, Tokyo, Japan, 204-0021
Novartis Investigative Site
Kunitachi, Tokyo, Japan, 186-0001
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 143-0023
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
Toshima-ku, Tokyo, Japan, 171-0021
Korea, Republic of
Novartis Investigative Site
Bucheon, Gyeonggi-do, Korea, Republic of, 424-717
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 137-701
Novartis Investigative Site
Koyang, Kyunggi, Korea, Republic of, 410-719
Novartis Investigative Site
Daegu, Korea, Republic of, 705-703
Novartis Investigative Site
Seoul, Korea, Republic of, 150-950
Novartis Investigative Site
Seoul, Korea, Republic of, 152-703
Taiwan
Novartis Investigative Site
Changhua, Taiwan, 500
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 10449
Novartis Investigative Site
Taipei, Taiwan, 114
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01256411     History of Changes
Other Study ID Numbers: CLCZ696A2219E1 
Study First Received: December 7, 2010
Results First Received: July 21, 2015
Last Updated: September 22, 2015
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
Korea: Korea Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Department of Health
Thailand: Ministry of Public Health

Keywords provided by Novartis:
hypertension
blood pressure
LCZ696
dual-acting
neprilysin
nep inhibitor
vasopeptidase
angiotensin receptor
angiotensin receptor neprilysin inhibitor (ARNi)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
LCZ 696
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 28, 2016