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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: March 26, 2013
Last verified: March 2013
History of Changes
  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
 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Frequency of adverse events, serious adverse events, and notable laboratory abnormalities [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reductions in mean sitting systolic blood pressure and mean sitting diastolic blood pressure of LCZ696 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Blood pressure control rate of <140/90 mmHg [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

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
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. Optional add-on of amlodipine (5-10 mg) and hydrochlorothiazide (12.5-25 mg) allowed (as applicable per local country regulations) for adequate blood pressure control.

  Eligibility

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
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, Tokyo, Japan, 204-0021
Novartis Investigative Site
Kunitachi, Tokyo, Japan, 186-0001
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 143-0023
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 142-0063
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 142-0053
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
Koyang, Kyunggi, Korea, Republic of, 410-719
Novartis Investigative Site
Daegu, Korea, Republic of, 705-717
Novartis Investigative Site
Seoul, Korea, Republic of, 152-703
Novartis Investigative Site
Seoul, Korea, Republic of, 137-701
Novartis Investigative Site
Seoul, Korea, Republic of, 150-950
Taiwan
Novartis Investigative Site
Changhua, Taiwan, 500
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan, 10002
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01256411     History of Changes
Other Study ID Numbers: CLCZ696A2219E1
Study First Received: December 7, 2010
Last Updated: March 26, 2013
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

ClinicalTrials.gov processed this record on May 19, 2013