Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01193101
First received: August 26, 2010
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

This study is a phase 2 study in patients with essential hypertension.


Condition Intervention Phase
Hypertension
Drug: Placebo to LCZ696
Drug: LCZ696
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction in mean sitting diastolic blood pressure. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in mean sitting systolic blood pressure [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events, serious adverse events, and notable laboratory abnormalities [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
  • Changes in office and ambulatory pulse pressure [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Changes in mean 24 hour, mean daytime and mean nighttime diastolic blood pressure and systolic blood pressure [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 392
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo to LCZ696
Placebo to LCZ696
Experimental: LCZ 100 mg Drug: LCZ696
LCZ696
Experimental: LCZ696 200 mg Drug: LCZ696
LCZ696
Experimental: LCZ696 400 mg Drug: LCZ696
LCZ696

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must give written informed consent before any assessment is performed.
  2. Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
  3. Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
  4. Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Exclusion Criteria:

  1. Patients with severe hypertension.
  2. Patients with history of angioedema, drug-related or otherwise
  3. Pregnant or nursing women
  4. Women of child-bearing potential , who do not use adequate birth control methods
  5. History or evidence of a secondary form of hypertension.
  6. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
  7. Diabetes mellitus.
  8. Previous or current diagnosis of heart failure (NYHA Class II-IV).
  9. Clinically significant valvular heart disease at the time of screening.

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: NCT01193101

Locations
China, Beijing
Investigative sites, China
Beijing, Beijing, China
China, Hebei
Investigative Site, China
Shi Jia Zhuang, Hebei, China
China, Zhejiang
Investigative site, China
Hangzhou, Zhejiang, China
China
Investigative site, China
Choungquing, China
Investigative site, China
Tianjin, China
Japan
Investigative Site, Japan
Yokohama, Kanagawa, Japan
Investigative Site, Japan
Shimotsuke, Tochigi, Japan
Investigative Sites, Japan
Bunkyo-ku, Tokyo, Japan
Investigative Site, Japan
Chiyoda-ku, Tokyo, Japan
Investigative Site, Japan
Kiyose City, Tokyo, Japan
Investigative Site, Japan
Kunitachi, Tokyo, Japan
Investigative Sites, Japan
Minato-ku, Tokyo, Japan
Investigative Site, Japan
Ota-ku, Tokyo, Japan
Invastigative Sites, Japan
Shinagawa-ku, Tokyo, Japan
Investigative site, Japan
Toshima-ku, Tokyo, Japan
Korea, Republic of
Investigative Site, South Korea
Bucheon-si, Gyeonggi-do, Korea, Republic of
Investigative Site, South Korea
Koyang-si, Gyeonggi-do, Korea, Republic of
Investigative Site, South Korea
Busan, Korea, Republic of
Investigative Site, South Korea
Daegu, Korea, Republic of
Investigative sites, South Korea
Seoul, Korea, Republic of
Taiwan
Investigative Site, Taiwan
Changhu, Taiwan
Investigative Site, Taiwan
Taichung, Taiwan
Investigative sites, Taiwan
Taipei, Taiwan
Thailand
Investigative sites, Thailand
Bangkok, Thailand
Investigative Site, Thailand
Chaing Mai, Thailand
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01193101     History of Changes
Other Study ID Numbers: CLCZ696A2219
Study First Received: August 26, 2010
Last Updated: May 30, 2011
Health Authority: China: Food and Drug Administration
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
ARNi
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014