- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02072382
The Hypotensive Effect of Metformin in Hypertensive Patients.
The Hypotensive Effect of Simvastatin in Hypertensive Patients: a Placebo-controlled Randomized Clinical Trial With 24-h Ambulatory Blood Pressure Monitoring
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary outcome was the difference in mean 24-hour blood pressure variation between the two groups after the intervention. The difference in mean of blood pressure during daytime and nighttime in 24h ambulatory blood pressure monitory, as well as the office BP and laboratory differences were considered secondary outcomes.
This randomized, double-blind parallel study was conducted in the Hypertension Clinic of the Department of Cardiology, Hospital de Clínicas de Porto Alegre (Porto Alegre, Brazil).
We selected hypertensive individuals (controlled or not) without diabetes aged 18-70 years.
Exclusion criteria: metformin intolerance, creatinine > 1,5 mg/dl Risks: adverse effects related to metformin use, mainly diarrhea and nausea Benefits: possible lower effect on arterial pressure Statistical analysis: sample size was calculated on the basis of a standard deviation of 8 mm Hg and effect size of 5 mm Hg in 24-h systolic ABPM and a two-sided significance level of 5%. A sample size of 42 patients per group was estimated to provide a power of 80% to reject the null hypothesis. Considering possible 10% of losses, the final calculated sample was 92 patients.
The baseline comparison between groups was performed using the Student t test for continuous variables and x2 for categorical variables. In each group, the change in BP by ABPM -24 h, daytime and nighttime, and laboratory tests was calculated by subtracting baseline values measured after the intervention period. The difference between groups was calculated by subtracting the variation observed between them (δ-values). The differences in BP variation and laboratory tests were analyzed by analysis of variance for repeated measures (MANOVA). For differences in pressure variation adjustment was considered for the baseline BP values (analysis of covariance). All tests were two-tailed and significance level was 5%. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 13.0.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
RS
-
Porto Alegre, RS, Brasilien
- Rekruttering
- Hospital de Clínicas de Porto Alegre
-
Kontakt:
- Corrêa Junior Vicente
- Telefonnummer: (51)99839395
- E-mail: vicentecorreajunior@terra.com.br
-
Underforsker:
- Correa Junior Vicente
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- hypertensive patients,
- aged 18-75 years
Exclusion Criteria:
- diabetes
- metformin intolerance
- creatinine level above 1.5 mg/dL
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Metformin
Metformin 850 mg twice a day for eight weeks versus Placebo
|
metformin 850mg twice a day for eight weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The effect of metformin on blood pressure
Tidsramme: eight weeks
|
The primary outcome was the difference in mean 24-hour BP variation between the two groups (metformin versus placebo) after the intervention.
|
eight weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The difference in mean of BP during daytime and nighttime in ABPM-24h, as well as the office BP and laboratory differences were considered secondary outcomes.
Tidsramme: eight weeks
|
eight weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Gus Miguel, Hospital de Clínicas de Porto Alegre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 120406
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