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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0954-315
- MK0954-315
- 2006_002
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