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Aliskiren Study of Safety and Efficacy in Senior Hypertensives (ASSESS)

14. april 2015 opdateret af: Novartis Pharmaceuticals

A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Follow-up to Compare Long-term Safety of an Aliskiren-based Regimen to a Ramipril-based Regimen in Hypertensive Patients ≥ 65 Years of Age

This study is designed to compare the blood pressure lowering efficacy of aliskiren, a combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to moderate hypertension. It will also compare the long-term safety of an aliskiren-based regimen to a ramipril-based regimen

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients ≥ 65 years of age with a clinical diagnosis of essential hypertension at Visit 1.
  • Mean sitting SBP (MSSBP) ≥ 140 mmHg and < 180 mmHg at Visit 2/Visit 201 and Visit 3.
  • Absolute MSSBP difference ≤ 20 mmHg between Visit 3 and the Visit immediately prior

Exclusion Criteria:

  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Severe hypertension (MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg) at Visit 1, Visit 2, Visit 201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in the pre-randomization period confirmed by office measurement.
  • Current treatment with any blocker of the renin angiotensin aldosterone system (RAAS) (aliskiren, ACE inhibitor, angiotensin receptor blocker or an aldosterone antagonist) and unable to discontinue this therapy.
  • Concurrent use of any anti-hypertensive medications except a stable dose of 3 months prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., tamsulosin [Flomax®] for benign prostatic hypertrophy), beta blockers for angina, or beta blocker ophthalmic preparations.
  • Contraindications to aliskiren, ramipril, amlodipine, or hydrochlorothiazide. Other protocol defined inclusion/exclusion criteria apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aliskiren monotherapy
Aliskiren 150 mg, once a day, force titrated to Aliskiren 300 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps
Medicin: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
Andre navne:
  • Rasilez, Tekturna
Medicin: Amlodipine
Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
Medicin: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.
Eksperimentel: Aliskiren dual therapy
Aliskiren 150 mg plus amlodipine 5 mg, once a day, force titrated to Aliskiren 300 mg plus amlodipine 5 mg after 8 weeks in 50% of patients. Optional titration of amlodipine 5 mg to 10 mg and optional addition/titration of hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps
Medicin: Aliskiren
Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
Andre navne:
  • Rasilez, Tekturna
Medicin: Amlodipine
Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
Medicin: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.
Aktiv komparator: Ramipril monotherapy
Ramipril 5 mg, once a day, force titrated to Ramipril 10 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps
Medicin: Amlodipine
Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
Medicin: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.
Medicin: Ramipril
Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8
Tidsramme: Baseline, Week 8
The change from baseline to week 8 in mean sitting systolic blood pressure will be analyzed for aliskiren monotherapy, dual therapy of aliskiren and amlodipine and ramipril monotherapy using ANCOVA model in which treatment arm, region and age (less than 75 and greater than or equal to 75 years) will be included as factors
Baseline, Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients with serious adverse events and adverse events
Tidsramme: Baseline, Week 8, average 2.5 years
Safety and tolerability of study treatments will be analyzed by comparing the frequency of serious adverse events and adverse events at the time frames
Baseline, Week 8, average 2.5 years
Number of patients with hyperkalemia, hypotension and reduction of estimated glomerular filtration rate (eGFR)
Tidsramme: Baseline, Week 8
The incidence of hyperkalemia, hypotension and reduction of eGFR will be compared between aliskiren monotherapy, aliskiren dual therapy with amlodipine and ramipril monotherapy
Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure (MSSBP) at the end of double blind period
Tidsramme: Baseline, end of double blind period (in average 2.5 years)
Change in mean sitting systolic blood pressure will be analyzed for the aliskiren-based regimen vs. the ramipril based regimen
Baseline, end of double blind period (in average 2.5 years)
Percentage of patients achieving blood pressure control
Tidsramme: Baseline, Week 8, average 2.5 years
Percentage of patients achieving blood pressure control, defined as mean sitting systolic BP below 140 mmHg and mean sitting diastolic BP below 90 mmHg, will be analyzed for the study treatments
Baseline, Week 8, average 2.5 years
Percentage of patients with major cardiovascular events
Tidsramme: Average 2.5 years
Percentage of patients with major cardiovascular events (defined as composite of cardiovascular death, resuscitated cardiac death, non-fatal stroke, non-fatal myocardial infarction, heart failure hospitalization and atrial fibrillation) will be analyzed for the aliskiren-based regimen and the ramipril-based regimen
Average 2.5 years
Number of patients with gastrointestinal tract cancer
Tidsramme: Average 2.5 years
The frequency of gastrointestinal tract cancer (malignant neoplasms of mouth, esophagus, stomach, small intestine, appendix, anus, gastrointestinal stroma, colon and rectum, excluding pancreatic, biliary tract and liver cancers) will be analyzed for the aliskiren-based regimen and the ramipril-based regimen
Average 2.5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Forventet)

1. juni 2018

Studieafslutning (Forventet)

1. juni 2018

Datoer for studieregistrering

Først indsendt

12. august 2013

Først indsendt, der opfyldte QC-kriterier

12. august 2013

Først opslået (Skøn)

14. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPP100A2370
  • 2013-001562-42 (EudraCT nummer)

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