Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01193101
First received: August 26, 2010
Last updated: May 30, 2011
Last verified: May 2011
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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:
- Patients must give written informed consent before any assessment is performed.
- 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).
- 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.
- Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.
Exclusion Criteria:
- Patients with severe hypertension.
- Patients with history of angioedema, drug-related or otherwise
- Pregnant or nursing women
- Women of child-bearing potential , who do not use adequate birth control methods
- History or evidence of a secondary form of hypertension.
- 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.
- Diabetes mellitus.
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Clinically significant valvular heart disease at the time of screening.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
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
| 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 June 17, 2013