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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0954-315
- MK0954-315
- 2006_002
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