- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00289887
Obese Hypertension Study (0954-315)
A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Obese male and female patients, ages 21-75 years, with high blood pressure
Exclusion Criteria:
- Patients cannot have any other severe cardiac conditions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 2
Placebo
|
Placebo to losartan once daily for 4 weeks in run-in period.
Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
|
Eksperimentell: 1
Losartan
|
Placebo to losartan once daily for 4 weeks in run-in period.
Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Tidsramme: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Tidsramme: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Tidsramme: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
Tidsramme: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
Tidsramme: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
Tidsramme: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0954-315
- MK0954-315
- 2006_002
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