A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

NCT01259297 | Terminated Phase 3 Results

• 2 other identifiers: CSPP100G23012009-010170-38
• Study Type: interventional
• Target: 2,336
• Locations: 18 countries
• Sites: 185

Brief Summary

This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

Conditions

Cardiovascular Events

Keywords

Aliskiren; Elderly; Major Cardiovascular Events; Effect of aliskiren-based regimen on major CV events (composite of CV death, non-fatal MI, non-fatal stroke and significant heart failure) in the elderly

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen

  The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure

  End of study (209 days (median))

• Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group

  The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure

  End of study (209 days (median))

Secondary Outcomes (4)

• Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)

  Baseline, End of study (209 days [median])

• Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)

  End of study (209 days [median])

• Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen

  End of study (209 days (median))

• Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen

  End of study (209 days (median))

Other Outcomes (2)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline (BL), 6 week, 6 month and 12 month

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

  Baseline (BL), 6 week, 6 month and 12 month

Study Arms (8)

Aliskiren + Amlodipine

EXPERIMENTAL

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.

Drug: Aliskiren; Drug: Amlodipine

Aliskiren + Hydrochlorothiazide (HCTZ)

EXPERIMENTAL

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.

Drug: Aliskiren; Drug: Hydrochlorothiazide (HCTZ)

Aliskiren + Placebo for Amlodipine

EXPERIMENTAL

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

Drug: Aliskiren; Drug: Placebo for Amlodipine

Aliskiren + Placebo for HCTZ

EXPERIMENTAL

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

Drug: Aliskiren; Drug: Placebo for Hydrochlorothiazide (HCTZ)

Amlodipine + Placebo for Aliskiren

EXPERIMENTAL

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

Drug: Amlodipine; Drug: Placebo for Aliskiren

HCTZ + Placebo for Aliskiren

EXPERIMENTAL

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

Drug: Hydrochlorothiazide (HCTZ); Drug: Placebo for Aliskiren

Placebo for Aliskiren + Placebo for Amlodipine

PLACEBO COMPARATOR

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

Drug: Placebo for Aliskiren; Drug: Placebo for Amlodipine

Placebo for Aliskiren + Placebo for HCTZ

PLACEBO COMPARATOR

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

Drug: Placebo for Aliskiren; Drug: Placebo for Hydrochlorothiazide (HCTZ)

Interventions

Aliskiren DRUG

Aliskiren 150/300 mg once daily

Aliskiren + Amlodipine; Aliskiren + Hydrochlorothiazide (HCTZ); Aliskiren + Placebo for Amlodipine; Aliskiren + Placebo for HCTZ

Amlodipine DRUG

Amlodipine 5 mg

Aliskiren + Amlodipine; Amlodipine + Placebo for Aliskiren

Hydrochlorothiazide (HCTZ) DRUG

HCTZ 12.5/25 mg

Aliskiren + Hydrochlorothiazide (HCTZ); HCTZ + Placebo for Aliskiren

Placebo for Aliskiren DRUG

Placebo for Aliskiren 300 mg

Amlodipine + Placebo for Aliskiren; HCTZ + Placebo for Aliskiren; Placebo for Aliskiren + Placebo for Amlodipine; Placebo for Aliskiren + Placebo for HCTZ

Placebo for Amlodipine DRUG

Placebo for Amlodipine

Aliskiren + Placebo for Amlodipine; Placebo for Aliskiren + Placebo for Amlodipine

Placebo for Hydrochlorothiazide (HCTZ) DRUG

Placebo for HCTZ 12.5/25 mg

Aliskiren + Placebo for HCTZ; Placebo for Aliskiren + Placebo for HCTZ

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3):
• 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
• 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

You may not qualify if:

• Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to Aliskiren, Amlodipine or Hydrochlorothiazide.
• Use of both thiazide diuretic and amlodipine or another calcium channel blocker. Patients on only one of these two classes of drugs are eligible
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
• Symptomatic heart failure, requiring the use of loop diuretics
• 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.
• Acute stroke \< 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome \< 1 months before informed consent
• Planned cardiac surgery or angioplasty \< 3 months after informed consent or having had the procedure \< 3 months before informed consent
• Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L
• 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)
• 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)
• 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
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (185)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Los Angeles, California, 90033, United States

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Northridge, California, 91325, United States

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Sylmar, California, 91342, United States

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Tucker, Georgia, 30084, United States

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Pocatello, Idaho, 83209, United States

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Haverhill, Massachusetts, 01830, United States

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St Louis, Missouri, 63125-4181, United States

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Westfiled, New York, 14787, United States

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Winston-Salem, North Carolina, 27157, United States

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Portland, Oregon, 97239, United States

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Falls Church, Virginia, 22042, United States

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Marshfield, Wisconsin, 54449, United States

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Milwaukee, Wisconsin, 53295, United States

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Buenos Aires, Buenos Aires, 2800, Argentina

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Buenos Aires, Buenos Aires, 8000, Argentina

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Buenos Aires, Buenos Aires, C1425AWC, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN, Argentina

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Coronel Suárez, Buenos Aires, B7540GHD, Argentina

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Jenin, Buenos Aires, 6000, Argentina

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Merlo, Buenos Aires, 1722, Argentina

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Quilmes, Buenos Aires, B1878GEG, Argentina

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San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

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Córdoba, Córdoba Province, X5000AAW, Argentina

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Cipolletti, Río Negro Province, 8324, Argentina

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Salta, Salta Province, A4406CLA, Argentina

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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina

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Rosario, Santa Fe Province, S2000AGE, Argentina

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Santa Fe, Santa Fe Province, S3000FWO, Argentina

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Venado Tuerto, Santa Fe Province, 2600, Argentina

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Uberaba, Minas Gerais, 38010-160, Brazil

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Campina Grande do Sul, Paraná, 83430-000, Brazil

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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

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Campinas, São Paulo, 13060-904, Brazil

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Marília, São Paulo, 17515-000, Brazil

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São José do Rio Preto, São Paulo, 15150-210, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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Votuporanga, São Paulo, 15500-003, Brazil

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Calgary, Alberta, T2N 4N1, Canada

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Edmonton, Alberta, T5A 4L8, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Winnipeg, Manitoba, R2H0R8, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Brampton, Ontario, L6Z 4N5, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Hamilton, Ontario, L8N 1T8, Canada

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London, Ontario, N6C 5J1, Canada

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Markham, Ontario, L6B 0P9, Canada

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Missisauga, Ontario, L4Y 1A6, Canada

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Newmarket, Ontario, L3Y 8C3, Canada

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Niagara Falls, Ontario, L2G 6A8, Canada

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North York, Ontario, M2N 7J5, Canada

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Ottawa, Ontario, K2A 3Z3, Canada

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Ottawa, Ontario, K2B 7K2, Canada

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Saint Catherines, Ontario, L2T 3Y4, Canada

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Toronto, Ontario, M4C5T2, Canada

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Toronto, Ontario, M4K 1N2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Lévis, Quebec, G6V 4Z5, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1L 3L5, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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St.Gorges de Beauce, Quebec, G5Y 4TB, Canada

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Terrebonne, Quebec, J6V 2H2, Canada

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Saskatoon, Saskatchewan, S7H 5M3, Canada

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Temuco, Cautin, Chile

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Osorno, Osorno, 5290000, Chile

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Vista Del Mar, Tarapacá, 2570017, Chile

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Temuca, TX, 4790869, Chile

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Santiago, Chile

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Barranquilla, Atlántico, Colombia

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Manizoles, Caldas Department, 1700, 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, 745, 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, 57-7, Colombia

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Armenia, Colombia

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Baranquilla, Colombia

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Barranquilla, Colombia

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Bogotá, 00000, Colombia

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Bogotá, Colombia

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Espinal, 11001, Colombia

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Montería, Colombia

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Beroun, Czech Republic, 266 01, Czechia

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Brandýs nad Labem, Czech Republic, 250 01, Czechia

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Prague, Czech Republic, 160 00, Czechia

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Prague, Czech Republic, Czechia

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Ústí nad Orlicí, Czech Republic, 562 18, Czechia

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Nový Jičín, 741 01, Czechia

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Prague, 146 24, Czechia

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Uherské Hradiště, 68601, Czechia

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Wiesbaden, Germany, 65191, Germany

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Berlin, 10117, Germany

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Frankfurt, 60594, Germany

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Melsungen, 34212, Germany

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Nuremberg, 90471, Germany

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Witten, 58455, Germany

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Komárom, Hungary, 2900, Hungary

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Budapest, 1125, Hungary

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Budapest, 1145, Hungary

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Gyöngyös, 3200, Hungary

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Kaposvár, 7400, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Pécs, 7624, Hungary

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Sopron, 9400, Hungary

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Szentes, 6600, Hungary

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Veszprém, 8200, Hungary

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Adoni, Andhra Pradesh, 518301, India

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Adoni, Andhra Pradesh, 518302, India

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Hyderabad, Andhra Pradesh, 500004, India

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Visakhapatnam, Andhra Pradesh, 530002, India

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Ahmedabad, Gujarat, 380006, India

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Ahmedabad, Gujarat, 380014, India

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Bangalore, Karnataka, 560034, India

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Bangalore, Karnataka, 560052, India

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Belagavi, Karnataka, 590001, India

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Bengaluru, Karnataka, 560034, India

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Nagpur, Maharashtra, 400 012, India

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Nagpur, Maharashtra, 440012, India

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Nagpur, Maharashtra, 44017, India

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Pune, Maharashtra, 411004, India

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Wardha, Maharashtra, 442102, India

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Jalandhar, Punjab, 144008, India

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Ludhiana, Punjab, 141421, India

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Bikaner, Rajasthan, 334003, India

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Tiruvannamalai, Tamil Nadu, 606603, India

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Trichy, Tamil Nadu, 620018, India

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Lucknow, Uttar Pradesh, 226003, India

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Chennai, 600086, India

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Hyderabad, 500 063, India

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Mumbai, 400064, India

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Nagpur, 440033, India

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Trichy, 620 018, 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, 13100, Israel

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Giv‘atayim, 53583, Israel

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Haifa, 34616, Israel

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Alor Star, Kedah, 05460, Malaysia

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Kota Bharu, Kelantan, 15586, Malaysia

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Kota Bharu, Kelantan, 16150, Malaysia

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Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

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Kuantan, Pahang, 25100, Malaysia

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Batu Caves, Selangor, 68100, Malaysia

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Kuala Lumpur, 50400, Malaysia

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Breda, 4811SW, Netherlands

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Eindhoven, 5611NJ, Netherlands

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Groningen, NL-9711 SG, Netherlands

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Leiderdorp, 2352 RA, Netherlands

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Rotterdam, 3001 HG, Netherlands

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Velp, 6883ES, Netherlands

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Zoetermeer, 2722 EP, Netherlands

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Dasmariñas, Cavite, Philippines

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Laoag, Ilocos Norte, 2900, Philippines

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Quezon City, National Capital Region, 1109, Philippines

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Biñan, 4024, Philippines

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Manila, 1000, Philippines

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Manila, Philippines

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Pasig, Philippines

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Quezon City, 1100, Philippines

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Paarl, Western Province, 7646, South Africa

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Bloemfontein, 9317, South Africa

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Durban, 4001, South Africa

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Pretoria, 0002, South Africa

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Ferrol, Galicia, 15405, Spain

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Madrid, Madrid, 28041, Spain

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Valencia, Valencia, 46010, Spain

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Port de Sagunt, 46520, Spain

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Dalby, 247 52, Sweden

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Gothenburg, 412 55, Sweden

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Gothenburg, 416 85, Sweden

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Malmo, 21152, Sweden

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Rättvik, 795 30, Sweden

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Novartis Investigative Site

Stockholm, 111 57, Sweden

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Related Publications (1)

• 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.

  PMID: 24616335 DERIVED

MeSH Terms

Interventions

aliskiren; Amlodipine; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Due to early termination, 1759 patients were randomized as against 11,000. Only 25 primary endpoints had accrued during median follow-up of 209 days as against planned 2000 in 5 years. These low numbers significantly limit interpretation of results.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 8, 2014
• Results First Posted: April 8, 2014

Record last verified: 2014-02

Locations

ES (4); US (14); AR (18); BR (9); IL (3); CL (5); CZ (8); HU (10); DE (6); CA (30); ZA (4); SE (6); PH (8); CO (17); NL (7); IN (26); IE (3); MY (7)