Status:
TERMINATED
Comparison of Awakening Versus Bedtime Dosing of Aspirin in Pre-Hypertension or Mild Essential Hypertension
Lead Sponsor:
University of Vigo
Collaborating Sponsors:
Hospital Clinico Universitario de Santiago
Bayer
Conditions:
High-Normal Blood Pressure
Mild Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Aspirin (ASA) has been shown to provide marked benefits in the prevention of cardiovascular events, although the potential direct effects of ASA on cardiovascular function remain uncertain. Previous s...
Detailed Description
This is a multi-center, prospective, randomized, four-arm, crossover study with double-blind design. At Visit 1 (week -1) patients will be assessed for eligibility for study participation. Subjects w...
Eligibility Criteria
Inclusion
- High-normal blood pressure
- Mild essential hypertension
Exclusion
- Moderate-severe hypertension.
- Secondary hypertension.
- Grade III/IV hypertensive retinopathy.
- Type 1 diabetes.
- Body mass index ≥ 35 kg/m2
- Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.
- Pregnant or lactating females.
- History of malignancy within the past five years.
- Shift workers.
- Obstructive sleep apnea.
- Use of disallowed concomitant medication.
- Intolerant to ambulatory BP monitoring (ABPM).
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00449618
Start Date
January 1 2007
End Date
December 1 2008
Last Update
January 5 2009
Active Locations (5)
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1
Centro de Salud de A Guarda
La Guardia, Pontevedra, Spain
2
Centro de Salud de Sardoma
Vigo, Pontevedra, Spain, 36214
3
Centro de Salud de A Doblada
Vigo, Pontevedra, Spain
4
C.S. Lérez
Pontevedra, Spain