Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
24. juni 2011 opdateret af: Novartis
An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
756
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Buenos Aires, Argentina
- Investigative Site
-
-
-
-
-
Amsterdam, Holland
- Investigative Site
-
-
-
-
-
Reykjavik, Island
- Investigative Site
-
-
-
-
-
Rome, Italien
- Investigative Site
-
-
-
-
-
Warsaw, Polen
- Investigative Site
-
-
-
-
-
Bratislava, Slovakiet
- Investigative Site
-
-
-
-
-
Prague, Tjekkiet
- Investigative Site
-
-
-
-
-
Berlin, Tyskland
- Investigative Site
-
-
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:
- Male and female outpatients 65 years of age and older.
- Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
- At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.
Exclusion Criteria:
- Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
- History or evidence of a secondary form of hypertension.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
- Current diagnosis of heart failure (NYHA Class II-IV).
- History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- Current angina pectoris requiring pharmacological therapy other than nitrates.
Other protocol-defined inclusion/exclusion criteria applied to the study.
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 |
|---|---|
|
Placebo komparator: Placebo
|
Placebo tablet taken once daily in the morning with a light meal.
|
|
Eksperimentel: Aliskiren 75 mg
|
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
|
|
Eksperimentel: Aliskiren 150 mg
|
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
|
|
Eksperimentel: Aliskiren 300 mg
|
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
Tidsramme: Baseline to end of study (Week 8)
|
Baseline to end of study (Week 8)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Tidsramme: Baseline to end of study (Week 8)
|
Baseline to end of study (Week 8)
|
|
|
Percentage of Patients Achieving Systolic Blood Pressure Response
Tidsramme: Baseline to end of study (Week 8)
|
Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.
|
Baseline to end of study (Week 8)
|
|
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Tidsramme: Baseline to end of study (Week 8)
|
Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study.
For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.
|
Baseline to end of study (Week 8)
|
|
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Tidsramme: Baseline to end of study (Week 8)
|
Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours.
The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment.
Similarly, the change from baseline in blood pressure was calculated at each hour.
The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh.
A negative change score indicates improvement.
|
Baseline to end of study (Week 8)
|
|
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Tidsramme: Baseline to end of study (week 8)
|
The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.
|
Baseline to end of study (week 8)
|
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. maj 2008
Primær færdiggørelse (Faktiske)
1. april 2009
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
25. juni 2008
Først indsendt, der opfyldte QC-kriterier
26. juni 2008
Først opslået (Skøn)
27. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CSPP100A2405
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .