Aliskiren Study of Safety and Efficacy in Senior Hypertensives (ASSESS)
14 april 2015 bijgewerkt door: 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
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Fase
- Fase 4
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
65 jaar en ouder (Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally.
These will be blinded with matching placebos for the 2 dose strengths.
Andere namen:
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.
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally.
It is an optional add-on to each arm.
|
|
Experimenteel: 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
|
Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally.
These will be blinded with matching placebos for the 2 dose strengths.
Andere namen:
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.
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally.
It is an optional add-on to each arm.
|
|
Actieve vergelijker: 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
|
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.
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally.
It is an optional add-on to each arm.
Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally.
These will be blinded with matching placebos for the 2 dose strengths.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of patients with serious adverse events and adverse events
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2015
Primaire voltooiing (Verwacht)
1 juni 2018
Studie voltooiing (Verwacht)
1 juni 2018
Studieregistratiedata
Eerst ingediend
12 augustus 2013
Eerst ingediend dat voldeed aan de QC-criteria
12 augustus 2013
Eerst geplaatst (Schatting)
14 augustus 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
16 april 2015
Laatste update ingediend die voldeed aan QC-criteria
14 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Hypertensie
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antihypertensiva
- Vaatverwijdende middelen
- Enzymremmers
- Proteaseremmers
- Natriuretische middelen
- Membraantransportmodulatoren
- Diuretica
- Calciumregulerende hormonen en middelen
- Calciumantagonisten
- Angiotensine-converterende enzymremmers
- Natriumchloride Symporter-remmers
- Amlodipine
- Hydrochloorthiazide
- Ramipril
Andere studie-ID-nummers
- CSPP100A2370
- 2013-001562-42 (EudraCT-nummer)
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