Comparison of the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose
Information source: University of Vigo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan, Enalapril (Drug); Ambulatory blood pressure monitoring (Device); Missing one dose (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University of Vigo Official(s) and/or principal investigator(s): Ramon C Hermida, Ph.D., Principal Investigator, Affiliation: University of Vigo
Summary
This study was designed in order to evaluate the blood pressure lowering effect of valsartan
compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the
renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of
hypertension. Previous studies had a significant limitation: the effect of a missing dose
was not evaluated after the whole 24 hours post missing dose period (48 hours after last
taken dose), and as a result, it does not imitate the real life situation of a missing dose.
Clinical Details
Official title: Prospective, Randomized, Open-Label Study in Patients With Mild-to-Moderate Essential Hypertension to Compare the Antihypertensive Efficacy Determined by Ambulatory Blood Pressure Monitoring of Valsartan and Enalapril After Missing One Dose
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To demonstrate the efficacy of valsartan by testing the hypothesis of superior 24 hrs diastolic BP lowering after missing dose compared with enalapril.
Secondary outcome: To demonstrate that valsartan is more effective than enalapril in terms of systolic 24 hrs BP lowering after missing dose.To show that valsartan is more effective than enalapril in reducing systolic and diastolic BP in the time interval 20-24 hours after dose administration. To show that valsartan has a more favorable effect than enalapril in smoothness index and through/peak ratio. To demonstrate that valsartan offers better safety profile than enalapril.
Detailed description:
The incidence of cardiovascular events, such as myocardial infarction, sudden cardiac death,
ventricular arrhythmias, stroke, myocardial ischemia and angina pectoris, reaches the peak
during the early morning hours. This period corresponds with the sharp increase in heart
rate (HR) and blood pressure (BP) (morning BP surge) which takes place upon arising form
overnight sleep. Furthermore, the RAAS is activated in the morning, and may contribute to
morning BP surge and to morning increase in cardiovascular risk. BP control over the entire
24 hours dosing interval, including the early morning period (18 - 24 hrs post-dosing) is
critical in order to prevent cardiovascular events, thus providing a better protection to
patients with essential hypertension. Apart from the significance of establishing the
24-hour BP lowering effect of an antihypertensive drug, it is fundamental to further
investigate the effect of a missing dose. Approximately 15 to 20% of hypertensive patients
do not recall to take their medication in average 3 days every month. During these periods,
patients could be on a higher risk of having a cardiovascular event resulting in a poorer
long-term prognosis. Therefore, it is crucial to establish the BP lowering effect of the
antihypertensive treatment beyond 24-hour of dose intake. Ambulatory blood pressure
monitoring (ABPM) has proven advantages compared to conventional BP measurement and
ambulatory BP levels are closely associated with target organ damage and clinical
cardiovascular events in hypertensive patients. However most of the studies using this
technique have been conducted with monitoring for a 24-hour period. In this study 48-hour
ABPM will be utilized in order to investigate the antihypertensive effect beyond 24 hours.
This study was designed in order to evaluate the BP lowering effect of valsartan compared to
enalapril over 24 hours after skipping one daily dose. Both drugs act on the RAAS and are
widely use for the treatment of hypertension. Enalapril was selected since a previous
similar study was performed using it as a comparison drug. An 8-week study with candesartan
and enalapril was done to evaluate their antihypertensive efficacy and their effect
duration. However, this study had a significant limitation, the effect of a missing dose was
not evaluated after the whole 24 hours post missing dose period (48 hours after last taken
dose), and as a result, it does not imitate the real life situation of a missing dose.
Therefore, we decided to perform the present study with the purpose of further investigate
the effect of these antihypertensive treatments beyond 24 hours in patients with mild to
moderate essential hypertension.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Essential hypertension (grade 1-2)
Exclusion Criteria:
- Severe hypertension
- Secondary hypertension
- Grade III/IV hypertensive retinopathy
- Type 1 diabetes
- Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.
- Pregnant or lactating females
- History of malignancy.
- shift workers
- intolerant to ABPM
Locations and Contacts
Hospital ClĂnico Universitario de Santiago, Santiago de Compostela 15706, Spain
Additional Information
Starting date: January 2005
Last updated: January 2, 2009
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