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| Sponsor: | University of Vigo |
|---|---|
| Collaborators: |
Hospital Clinico Universitario de Santiago Novartis |
| Information provided by: | University of Vigo |
| ClinicalTrials.gov Identifier: | NCT00302705 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan, Enalapril Device: Ambulatory blood pressure monitoring Procedure: Missing one dose |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 150 |
| Study Start Date: | January 2005 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Valsartan: Active Comparator
160 mg/day on awakening
|
Drug: Valsartan, Enalapril
160 mg valsartan versus 10-20 mg enalapril
Device: Ambulatory blood pressure monitoring
Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
Procedure: Missing one dose
Patients skip the dose the second day of monitoring
|
|
Enalapril: Active Comparator
10-20 mg/day on awakening
|
Drug: Valsartan, Enalapril
160 mg valsartan versus 10-20 mg enalapril
Device: Ambulatory blood pressure monitoring
Blood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
Procedure: Missing one dose
Patients skip the dose the second day of monitoring
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clínico Universitario de Santiago | |
| Santiago de Compostela, Spain, 15706 | |
| Principal Investigator: | Ramon C Hermida, Ph.D. | University of Vigo |
More Information
| Responsible Party: | University of Vigo ( Ramon C. Hermida ) |
| Study ID Numbers: | VAL-489A2425, 2004-001725-25 |
| Study First Received: | March 13, 2006 |
| Last Updated: | January 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00302705 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
Ambulatory blood pressure monitoring Valsartan Enalapril Missing dose |
|
Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Enalapril Enalaprilat Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Valsartan Hypertension |