Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
NCT ID: NCT01663233
Last Updated: 2015-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2012-08-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LCZ696 and amlodipine
Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
LCZ696
LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.
Amlodipine
Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
Amlodipine
Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
Amlodipine
Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
Placebo
Matching placebo to LCZ696
Interventions
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LCZ696
LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.
Amlodipine
Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
Placebo
Matching placebo to LCZ696
Eligibility Criteria
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Inclusion Criteria
Untreated patients must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and \< 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and \< 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201).
Patients must successfully complete ABPM and pass technical requirements at Visit 201.
Exclusion Criteria
History of angioedema, drug-related or otherwise. History or evidence of a secondary form of hypertension. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Chongqing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan
Novartis Investigative Site
Kiyose, Tokyo, Japan
Novartis Investigative Site
Kunitachi, Tokyo, Japan
Novartis Investigative Site
Shibuya-ku, Tokyo, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, Japan
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Kuala Lumpur, , Malaysia
Novartis Investigative Site
Quezon City, Manila, Philippines
Novartis Investigative Site
Manila, National Capital Region, Philippines
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Valenzuela, , Philippines
Novartis Investigative Site
Busan, Busan, South Korea
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
Novartis Investigative Site
Koyang, Kyunggi, South Korea
Novartis Investigative Site
Seoul, Seoul, South Korea
Novartis Investigative Site
Daegu, , South Korea
Novartis Investigative Site
Daegu, , South Korea
Novartis Investigative Site
Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, ROC, Taiwan
Countries
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Other Identifiers
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CLCZ696A2319
Identifier Type: -
Identifier Source: org_study_id
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