Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
5. juli 2011 opdateret af: Novartis
An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
485
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Moscow, Den Russiske Føderation
- Investigative Site
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Manilla, Filippinerne
- Investigative Site
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Bucharest, Rumænien
- Investigative Site
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Singapore, Singapore
- Investigative Site
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Madrid, Spanien
- Investigative Site
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Berlin, Tyskland
- Investigative Site
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Outpatients ≥ 18 years of age
- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2
Exclusion Criteria:
- Mild to moderate hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
- Patients on a combination of 3 or more antihypertensive medications
Other protocol-defined inclusion/exclusion criteria may 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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Aliskiren/amlodipine 300/10 mg tablet
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week.
For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
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Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed.
In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
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Aktiv komparator: Amlodipine 10 mg capsule
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week.
For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
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Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed.
In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean Sitting Systolic Blood Pressure (msSBP)
Tidsramme: Baseline to end of study (Week 8)
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Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
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Baseline to end of study (Week 8)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean Sitting Diastolic Blood Pressure (msDBP)
Tidsramme: Baseline to end of study (Week 8)
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Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)
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Baseline to end of study (Week 8)
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Systolic Blood Pressure Response
Tidsramme: Baseline to end of study (Week 8)
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Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)
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Baseline to end of study (Week 8)
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Diastolic Blood Pressure Response
Tidsramme: Baseline to end of study (Week 8)
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Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)
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Baseline to end of study (Week 8)
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Blood Pressure Control
Tidsramme: End of study (Week 8)
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Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study
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End of study (Week 8)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. januar 2009
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
10. februar 2009
Først indsendt, der opfyldte QC-kriterier
10. februar 2009
Først opslået (Skøn)
11. februar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. juli 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juli 2011
Sidst verificeret
1. juli 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CSPA100A2306
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