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Cardiovascular EventsPhase 3APOLLONCT01259297

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

A Phase 3 study testing Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in people with Cardiovascular Events, run by Novartis Pharmaceuticals at 185 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cardiovascular Events
What is being tested?
Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,336 participants
Where
185 sitesin 18 countries
Study dates
Jan 2011to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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
  • 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
  • Men and women aged ≥ 70 years if they do not have any of the above (primary prevention)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

185 sites in 18 countries.

185 sites in 18 countries

Canada30 sites

  • Novartis Investigative Site

    Brampton, Ontario, L6Z 4N5

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N1

  • Novartis Investigative Site

    Coquitlam, British Columbia, V3K 3P4

  • Novartis Investigative Site

    Edmonton, Alberta, T5A 4L8

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 2X2

  • Novartis Investigative Site

    Hamilton, Ontario, L8M 1K7

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 1T8

  • Novartis Investigative Site

    Lévis, Quebec, G6V 4Z5

  • Novartis Investigative Site

    London, Ontario, N6C 5J1

  • Novartis Investigative Site

    Markham, Ontario, L6B 0P9

  • Novartis Investigative Site

    Missisauga, Ontario, L4Y 1A6

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1T8

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 8C3

  • Novartis Investigative Site

    Niagara Falls, Ontario, L2G 6A8

  • Novartis Investigative Site

    North York, Ontario, M2N 7J5

  • Novartis Investigative Site

    Ottawa, Ontario, K2A 3Z3

  • Novartis Investigative Site

    Ottawa, Ontario, K2B 7K2

  • Novartis Investigative Site

    Québec, Quebec, G1L 3L5

  • Novartis Investigative Site

    Saint Catherines, Ontario, L2T 3Y4

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G2

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7H 5M3

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    St.Gorges de Beauce, Quebec, G5Y 4TB

  • Novartis Investigative Site

    Terrebonne, Quebec, J6V 2H2

  • Novartis Investigative Site

    Toronto, Ontario, M4C5T2

  • Novartis Investigative Site

    Toronto, Ontario, M4K 1N2

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Winnipeg, Manitoba, R2H0R8

Other trials in Canada

India26 sites

  • Novartis Investigative Site

    Adoni, Andhra Pradesh, 518301

  • Novartis Investigative Site

    Adoni, Andhra Pradesh, 518302

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380006

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380014

  • Novartis Investigative Site

    Bangalore, Karnataka, 560034

  • Novartis Investigative Site

    Bangalore, Karnataka, 560052

  • Novartis Investigative Site

    Belagavi, Karnataka, 590001

  • Novartis Investigative Site

    Bengaluru, Karnataka, 560034

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    Chennai, 600086

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500004

  • Novartis Investigative Site

    Hyderabad, 500 063

  • Novartis Investigative Site

    Jalandhar, Punjab, 144008

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Novartis Investigative Site

    Ludhiana, Punjab, 141421

  • Novartis Investigative Site

    Mumbai, 400064

  • Novartis Investigative Site

    Nagpur, Maharashtra, 400 012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 44017

  • Novartis Investigative Site

    Nagpur, 440033

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

  • Novartis Investigative Site

    Tiruvannamalai, Tamil Nadu, 606603

  • Novartis Investigative Site

    Trichy, Tamil Nadu, 620018

  • Novartis Investigative Site

    Trichy, 620 018

  • Novartis Investigative Site

    Visakhapatnam, Andhra Pradesh, 530002

  • Novartis Investigative Site

    Wardha, Maharashtra, 442102

Other trials in India

Argentina18 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, 2800

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, 8000

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1425AWC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires

  • Novartis Investigative Site

    Cipolletti, Río Negro Province, 8324

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000AAW

  • Novartis Investigative Site

    Coronel Suárez, Buenos Aires, B7540GHD

  • Novartis Investigative Site

    Jenin, Buenos Aires, 6000

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600FZN

  • Novartis Investigative Site

    Merlo, Buenos Aires, 1722

  • Novartis Investigative Site

    Quilmes, Buenos Aires, B1878GEG

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AGE

  • Novartis Investigative Site

    Salta, Salta Province, A4406CLA

  • Novartis Investigative Site

    San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL

  • Novartis Investigative Site

    San Nicolás de los Arroyos, Buenos Aires, 2900

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FWO

  • Novartis Investigative Site

    Venado Tuerto, Santa Fe Province, 2600

Other trials in Argentina

Colombia17 sites

  • Novartis Investigative Site

    Armenia

  • Novartis Investigative Site

    Baranquilla

  • Novartis Investigative Site

    Barranquilla, Atlántico

  • Novartis Investigative Site

    Barranquilla, Colombia

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Bogota, Cundinamarca

  • Novartis Investigative Site

    Bogotá, 00000

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Cali, Colombia

  • Novartis Investigative Site

    Cartagena, Departamento de Bolívar

  • Novartis Investigative Site

    Cartegena, Colombia

  • Novartis Investigative Site

    Espinal, 11001

  • Novartis Investigative Site

    Floridablanca, Santander Department, 57-7

  • Novartis Investigative Site

    Manizoles, Caldas Department, 1700

  • Novartis Investigative Site

    Montería

  • Novartis Investigative Site

    Pasto, Colombia, 745

  • Novartis Investigative Site

    Pereira, Risaralda Department

Other trials in Colombia

United States14 sites

  • Novartis Investigative Site

    Birmingham, Alabama, 35205

  • Novartis Investigative Site

    Falls Church, Virginia, 22042

  • Novartis Investigative Site

    Haverhill, Massachusetts, 01830

  • Novartis Investigative Site

    Los Angeles, California, 90033

  • Novartis Investigative Site

    Marshfield, Wisconsin, 54449

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53295

  • Novartis Investigative Site

    Northridge, California, 91325

  • Novartis Investigative Site

    Pocatello, Idaho, 83209

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Novartis Investigative Site

    St Louis, Missouri, 63125-4181

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    Tucker, Georgia, 30084

  • Novartis Investigative Site

    Westfiled, New York, 14787

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Hungary10 sites

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Gyöngyös, 3200

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Komárom, Hungary, 2900

  • Novartis Investigative Site

    Mosonmagyaróvár, 9200

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Sopron, 9400

  • Novartis Investigative Site

    Szentes, 6600

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

Brazil9 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

  • Novartis Investigative Site

    Campina Grande do Sul, Paraná, 83430-000

  • Novartis Investigative Site

    Campinas, São Paulo, 13060-904

  • Novartis Investigative Site

    Marília, São Paulo, 17515-000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    Uberaba, Minas Gerais, 38010-160

  • Novartis Investigative Site

    Votuporanga, São Paulo, 15500-003

Other trials in Brazil

Czechia8 sites

  • Novartis Investigative Site

    Beroun, Czech Republic, 266 01

  • Novartis Investigative Site

    Brandýs nad Labem, Czech Republic, 250 01

  • Novartis Investigative Site

    Nový Jičín, 741 01

  • Novartis Investigative Site

    Prague, Czech Republic, 160 00

  • Novartis Investigative Site

    Prague, Czech Republic

  • Novartis Investigative Site

    Prague, 146 24

  • Novartis Investigative Site

    Uherské Hradiště, 68601

  • Novartis Investigative Site

    Ústí nad Orlicí, Czech Republic, 562 18

Other trials in Czechia

Philippines8 sites

  • Novartis Investigative Site

    Biñan, 4024

  • Novartis Investigative Site

    Dasmariñas, Cavite

  • Novartis Investigative Site

    Laoag, Ilocos Norte, 2900

  • Novartis Investigative Site

    Manila, 1000

  • Novartis Investigative Site

    Manila

  • Novartis Investigative Site

    Pasig

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1109

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

Malaysia7 sites

  • Novartis Investigative Site

    Alor Star, Kedah, 05460

  • Novartis Investigative Site

    Batu Caves, Selangor, 68100

  • Novartis Investigative Site

    Kota Bharu, Kelantan, 15586

  • Novartis Investigative Site

    Kota Bharu, Kelantan, 16150

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 56000

  • Novartis Investigative Site

    Kuala Lumpur, 50400

  • Novartis Investigative Site

    Kuantan, Pahang, 25100

Other trials in Malaysia

Netherlands7 sites

  • Novartis Investigative Site

    Breda, 4811SW

  • Novartis Investigative Site

    Eindhoven, 5611NJ

  • Novartis Investigative Site

    Groningen, NL-9711 SG

  • Novartis Investigative Site

    Leiderdorp, 2352 RA

  • Novartis Investigative Site

    Rotterdam, 3001 HG

  • Novartis Investigative Site

    Velp, 6883ES

  • Novartis Investigative Site

    Zoetermeer, 2722 EP

Other trials in Netherlands

Germany6 sites

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Frankfurt, 60594

  • Novartis Investigative Site

    Melsungen, 34212

  • Novartis Investigative Site

    Nuremberg, 90471

  • Novartis Investigative Site

    Wiesbaden, Germany, 65191

  • Novartis Investigative Site

    Witten, 58455

Other trials in Germany

Sweden6 sites

  • Novartis Investigative Site

    Dalby, 247 52

  • Novartis Investigative Site

    Gothenburg, 412 55

  • Novartis Investigative Site

    Gothenburg, 416 85

  • Novartis Investigative Site

    Malmö, 21152

  • Novartis Investigative Site

    Rättvik, 795 30

  • Novartis Investigative Site

    Stockholm, 111 57

Other trials in Sweden

Chile5 sites

  • Novartis Investigative Site

    Osorno, Osorno, 5290000

  • Novartis Investigative Site

    Santiago

  • Novartis Investigative Site

    Temuca, TX, 4790869

  • Novartis Investigative Site

    Temuco, Cautin

  • Novartis Investigative Site

    Vista Del Mar, Tarapacá, 2570017

Other trials in Chile

South Africa4 sites

  • Novartis Investigative Site

    Bloemfontein, 9317

  • Novartis Investigative Site

    Durban, 4001

  • Novartis Investigative Site

    Paarl, Western Province, 7646

  • Novartis Investigative Site

    Pretoria, 0002

Other trials in South Africa

Spain4 sites

  • Novartis Investigative Site

    Ferrol, Galicia, 15405

  • Novartis Investigative Site

    Madrid, Madrid, 28041

  • Novartis Investigative Site

    Port de Sagunt, 46520

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

Ireland3 sites

  • Novartis Investigative Site

    Ballinsloe, Galway

  • Novartis Investigative Site

    Galway, Ireland

  • Novartis Investigative Site

    Gorey, Co. Wexford

Other trials in Ireland

Israel3 sites

  • Novartis Investigative Site

    Giv‘atayim, 53583

  • Novartis Investigative Site

    Haifa, 34616

  • Novartis Investigative Site

    Safed, Israel, 13100

Other trials in Israel

About this study

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.

Read the detailed description

This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.

Being tested
Aliskiren, Amlodipine, Hydrochlorothiazide (HCTZ), Placebo for Aliskiren, Placebo for Amlodipine
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AliskirenDrug

    Aliskiren 150/300 mg once daily

  • AmlodipineDrug

    Amlodipine 5 mg

  • Hydrochlorothiazide (HCTZ)Drug

    HCTZ 12.5/25 mg

  • Placebo for AliskirenDrug

    Placebo for Aliskiren 300 mg

  • Placebo for AmlodipineDrug

    Placebo for Amlodipine

  • Placebo for Hydrochlorothiazide (HCTZ)Drug

    Placebo for HCTZ 12.5/25 mg

Study groups in NCT01259297
Study groupRoleWhat they receive
Aliskiren + AmlodipineExperimentalIn 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.
Receives: Drug: Aliskiren; Drug: Amlodipine
Aliskiren + Hydrochlorothiazide (HCTZ)ExperimentalIn 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.
Receives: Drug: Aliskiren; Drug: Hydrochlorothiazide (HCTZ)
Aliskiren + Placebo for AmlodipineExperimentalIn 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
Receives: Drug: Aliskiren; Drug: Placebo for Amlodipine
Aliskiren + Placebo for HCTZExperimentalIn 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
Receives: Drug: Aliskiren; Drug: Placebo for Hydrochlorothiazide (HCTZ)
Amlodipine + Placebo for AliskirenExperimentalIn 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
Receives: Drug: Amlodipine; Drug: Placebo for Aliskiren
HCTZ + Placebo for AliskirenExperimentalIn 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
Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Placebo for Aliskiren
Placebo for Aliskiren + Placebo for AmlodipinePlacebo comparatorIn 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
Receives: Drug: Placebo for Aliskiren; Drug: Placebo for Amlodipine
Placebo for Aliskiren + Placebo for HCTZPlacebo comparatorIn 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
Receives: Drug: Placebo for Aliskiren; Drug: Placebo for Hydrochlorothiazide (HCTZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: End of study (209 days (median))

  2. 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

    Measured: End of study (209 days (median))

Secondary outcomes (4)

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

    Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:

    • Community Cognition (maximum of scores of questions 1 to 6);
    • Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);
    • Mobility (maximum of scores of questions 11 and 12);.
    • Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension's total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities.

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

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

    Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).

    Part II of SAGE included 2 dimensions:

    • "Normal" if the scores of all SAGE questions is 0 (i.e., No difficulty)
    • "Mobility Only" if scores of both SAGE questions 11 and 12 are 0

    Measured: End of study (209 days [median])

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

    The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:

    • End-stage renal disease [ESRD] requiring dialysis or transplantation
    • Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2.

    Measured: End of study (209 days (median))

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

    The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date.

    Measured: End of study (209 days (median))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Why it stopped: Terminated early in agreement with Health Authorities for feasibility reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259297
Sponsor's protocol ID
CSPP100G2301
Other IDs
2009-010170-38, 2009
Acronym
APOLLO
Status last verified
Feb 2014
First submitted
10 Dec 2010
Last updated
8 Apr 2014

Publications

  • 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.

    PubMed 24616335

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in people with Cardiovascular Events, run by Novartis Pharmaceuticals at 185 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in Canada, India, Argentina, Colombia, United States and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen (time frame: End of study (209 days (median))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01259297, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.

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