A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
NCT ID: NCT01259297
Last Updated: 2014-04-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2336 participants
INTERVENTIONAL
2011-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Aliskiren + Amlodipine
In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period.
Aliskiren
Aliskiren 150/300 mg once daily
Amlodipine
Amlodipine 5 mg
Aliskiren + Hydrochlorothiazide (HCTZ)
In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.
In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily.
Aliskiren
Aliskiren 150/300 mg once daily
Hydrochlorothiazide (HCTZ)
HCTZ 12.5/25 mg
Aliskiren + Placebo for Amlodipine
In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + Placebo for Amlodipine 5 mg
Aliskiren
Aliskiren 150/300 mg once daily
Placebo for Amlodipine
Placebo for Amlodipine
Aliskiren + Placebo for HCTZ
In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received Aliskiren 300 mg + Placebo for HCTZ 25 mg once daily
Aliskiren
Aliskiren 150/300 mg once daily
Placebo for Hydrochlorothiazide (HCTZ)
Placebo for HCTZ 12.5/25 mg
Amlodipine + Placebo for Aliskiren
In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily
Amlodipine
Amlodipine 5 mg
Placebo for Aliskiren
Placebo for Aliskiren 300 mg
HCTZ + Placebo for Aliskiren
In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily
Hydrochlorothiazide (HCTZ)
HCTZ 12.5/25 mg
Placebo for Aliskiren
Placebo for Aliskiren 300 mg
Placebo for Aliskiren + Placebo for Amlodipine
In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily
Placebo for Aliskiren
Placebo for Aliskiren 300 mg
Placebo for Amlodipine
Placebo for Amlodipine
Placebo for Aliskiren + Placebo for HCTZ
In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.
In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily
Placebo for Aliskiren
Placebo for Aliskiren 300 mg
Placebo for Hydrochlorothiazide (HCTZ)
Placebo for HCTZ 12.5/25 mg
Interventions
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Aliskiren
Aliskiren 150/300 mg once daily
Amlodipine
Amlodipine 5 mg
Hydrochlorothiazide (HCTZ)
HCTZ 12.5/25 mg
Placebo for Aliskiren
Placebo for Aliskiren 300 mg
Placebo for Amlodipine
Placebo for Amlodipine
Placebo for Hydrochlorothiazide (HCTZ)
Placebo for HCTZ 12.5/25 mg
Eligibility Criteria
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Inclusion Criteria
1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease
* Previous myocardial infarction or
* Stable angina or unstable angina with documented multi-vessel coronary artery disease, \> 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or
* Multi-vessel PCI, or
* Multi-vessel CABG surgery \> 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA \< 1 year before informed consent Peripheral artery disease
* Previous limb bypass surgery or percutaneous transluminal angioplasty, or
* Previous limb or foot amputation, or
* History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (\> 50%) documented by angiography or non-invasive testing
* Diabetes mellitus: High-risk diabetics with evidence of end-organ damage
2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention):
* History of dyslipidemia, defined as LDL cholesterol \> 3.5 mmol/L (135 mg/dL) or HDL\< 1.3 mmol/L (50 mg/dL) in women or \< 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio \> 5
* History of current or recent smoking (regular tobacco use within 5 years)
* Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men
* History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L \[101 to 124 mg/dL\]), or impaired glucose tolerance (IGT - fasting plasma glucose \< 7 mmol/L \[126 mg/dL\] but 2 hour glucose 7.8 to 11.0 mmol/L \[140 to 198 mg/dL\]) or type 2 diabetes
* Renal dysfunction: eGFR\< 60 ml/min/1.73m2 but \> 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea
* Clinical evidence of left ventricular hypertrophy
3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention)
Exclusion Criteria
2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker. Patients on only one of these two classes of drugs are eligible
3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
4. Symptomatic heart failure, requiring the use of loop diuretics
5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease.
6. Acute stroke \< 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome \< 1 months before informed consent
7. Planned cardiac surgery or angioplasty \< 3 months after informed consent or having had the procedure \< 3 months before informed consent
8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L
9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST \> 3x upper limit of normal (ULN)
10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR \< 60 ml/min/1.73m2 (MDRD formula)
11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases
12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
65 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
Birmingham, Alabama, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Sylmar, California, United States
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Tucker, Georgia, United States
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Pocatello, Idaho, United States
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Haverhill, Massachusetts, United States
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St Louis, Missouri, United States
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Westfiled, New York, United States
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Winston-Salem, North Carolina, United States
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Portland, Oregon, United States
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Falls Church, Virginia, United States
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Marshfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Bs As, Buenos Aires, Argentina
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Coronel Suárez, Buenos Aires, Argentina
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Jenin, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Merlo, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Nicolás de los Arroyos, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Cipolletti, Río Negro Province, Argentina
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Salta, Salta Province, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Venado Tuerto, Santa Fe Province, Argentina
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Belo Horizonte, Minas Gerais, Brazil
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Uberaba, Minas Gerais, Brazil
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Campina Grande do Sul, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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Marília, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Votuporanga, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Missisauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Niagara Falls, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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St.Gorges de Beauce, Quebec, Canada
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Terrebonne, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Temuco, Cautin, Chile
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Osorno, Osorno, Chile
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Vista Del Mar, Tarapacá, Chile
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Temuca, TX, Chile
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Santiago, , Chile
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Barranquilla, Atlántico, Colombia
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Manizoles, Caldas Department, Colombia
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Barranquilla, Colombia, Colombia
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Cali, Colombia, Colombia
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Cartegena, Colombia, Colombia
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Pasto, Colombia, Colombia
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Bogota, Cundinamarca, Colombia
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Cartagena, Departamento de Bolívar, Colombia
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Pereira, Risaralda Department, Colombia
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Floridablanca, Santander Department, Colombia
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Armenia, , Colombia
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Baranquilla, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Espinal, , Colombia
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Montería, , Colombia
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Beroun, Czech Republic, Czechia
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Brandýs nad Labem, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Ústí nad Orlicí, Czech Republic, Czechia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Wiesbaden, Germany, Germany
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Berlin, , Germany
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Frankfurt, , Germany
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Melsungen, , Germany
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Nuremberg, , Germany
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Witten, , Germany
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Komárom, Hungary, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Kaposvár, , Hungary
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Mosonmagyaróvár, , Hungary
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Pécs, , Hungary
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Sopron, , Hungary
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Szentes, , Hungary
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Veszprém, , Hungary
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Adoni, Andhra Pradesh, India
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Adoni, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Belagavi, Karnataka, India
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Bengaluru, Karnataka, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Wardha, Maharashtra, India
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Jalandhar, Punjab, India
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Ludhiana, Punjab, India
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Bikaner, Rajasthan, India
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Tiruvannamalai, Tamil Nadu, India
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Trichy, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Chennai, , India
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Hyderabad, , India
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Mumbai, , India
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Nagpur, , India
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Trichy, , India
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Gorey, Co. Wexford, Ireland
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Ballinsloe, Galway, Ireland
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Galway, Ireland, Ireland
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Safed, Israel, Israel
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Giv‘atayim, , Israel
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Haifa, , Israel
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Alor Star, Kedah, Malaysia
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Kota Bharu, Kelantan, Malaysia
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Kota Bharu, Kelantan, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuantan, Pahang, Malaysia
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Batu Caves, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Leiderdorp, , Netherlands
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Rotterdam, , Netherlands
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Velp, , Netherlands
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Zoetermeer, , Netherlands
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Dasmariñas, Cavite, Philippines
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Laoag, Ilocos Norte, Philippines
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Quezon City, National Capital Region, Philippines
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Biñan, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Paarl, Western Province, South Africa
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Bloemfontein, , South Africa
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Durban, , South Africa
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Pretoria, , South Africa
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Ferrol, Galicia, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Port de Sagunt, , Spain
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Dalby, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Malmo, , Sweden
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Rättvik, , Sweden
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Stockholm, , Sweden
Countries
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References
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Teo KK, Pfeffer M, Mancia G, O'Donnell M, Dagenais G, Diaz R, Dans A, Liu L, Bosch J, Joseph P, Copland I, Jung H, Pogue J, Yusuf S; Aliskiren Prevention of Later Life Outcomes trial Investigators. Aliskiren alone or with other antihypertensives in the elderly with borderline and stage 1 hypertension: the APOLLO trial. Eur Heart J. 2014 Jul;35(26):1743-51. doi: 10.1093/eurheartj/ehu079. Epub 2014 Mar 9.
Other Identifiers
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2009-010170-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSPP100G2301
Identifier Type: -
Identifier Source: org_study_id
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