Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
NCT ID: NCT01692301
Last Updated: 2016-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
454 participants
INTERVENTIONAL
2012-12-31
2015-04-30
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
DOUBLE
Study Groups
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LCZ696 (sacubitril/valsartan)
Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
LCZ696
200 mg tablet
LCZ696 matching placebo
LCZ696 Matching Placebo tablet
Olmesartan matching placebo
Olmesartan matching placebo capsule
amlodipine
amlodipine 2.5 mg or 5 mg tablets
hydrochlorothiazide
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Olmesartan
Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
Olmesartan
20 mg and 40 mg capsules
LCZ696 matching placebo
LCZ696 Matching Placebo tablet
amlodipine
amlodipine 2.5 mg or 5 mg tablets
hydrochlorothiazide
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Interventions
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LCZ696
200 mg tablet
Olmesartan
20 mg and 40 mg capsules
LCZ696 matching placebo
LCZ696 Matching Placebo tablet
Olmesartan matching placebo
Olmesartan matching placebo capsule
amlodipine
amlodipine 2.5 mg or 5 mg tablets
hydrochlorothiazide
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
3. Untreated patients must have an office msSBP ≥150 mmHg and \<180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
4. Treated patients must have an office msSBP ≥140 mmHg and \<180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and \<180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
5. All patients must have pulse pressure \>60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.
Exclusion Criteria
2. History of angioedema, drug-related or otherwise.
3. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.
60 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
Clearwater, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Belzoni, Mississippi, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
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Cincinnati, Ohio, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Pasadena, Texas, United States
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Caba, Buenos Aires, Argentina
Novartis Investigative Site
Ramos Mejía, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Barranquilla, , Colombia
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Paris, , France
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Berlin, , Germany
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Nuremberg, , Germany
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Athens, Athens, Greece
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Athens, Athens, Greece
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Thessaloniki, Greece, Greece
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Treviglio, BG, Italy
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Pisa, PI, Italy
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San Daniele del Friuli, UD, Italy
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Shimotsuke, Tochigi, Japan
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Bucheon-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
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Seville, Andalusia, Spain
Novartis Investigative Site
Jerez de la Frontera, Cadiz, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Centelles, Catalonia, Spain
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Terrassa, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Port de Sagunt, Valencia, Spain
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Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, ROC, Taiwan
Countries
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References
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Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.
Other Identifiers
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2012-002899-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696A2216
Identifier Type: -
Identifier Source: org_study_id
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