Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473174
Status:
COMPLETED
Last Update Posted:
2009-09-02
First Post:
2007-05-11
Brief Title:
Comparison of Awakening Versus Bedtime Dosing of Ramipril in Subjects With Essential Hypertension
Sponsor:
University of Vigo
Organization:
University of Vigo
Study Overview
Official Title:
A Prospective Randomized Open Label Blinded-endpoint Study to Compare Awakening Versus Bedtime Administration of 5-10 mg Ramipril in Terms of Systolic Blood Pressure Lowering Determined by ABPM in Subjects With Mild-to-moderate Essential
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYCCRA
Brief Summary:
This prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mgday when administered as a monotherapy either upon awakening from nighttime sleep or at bedtime to diurnally active patients with grade 1 or 2 essential hypertension who will be evaluated by 48-hour ABPM before and after pharmacologic intervention The benefits from this trial may be extremely important taking into account
1 the high prevalence of non-dipping among patients with essential hypertension
2 the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean
3 the lacking information on the administration-time dependent effects on BP of ramipril a widely used ACEI in doses of 5-10 mgday
1 the high prevalence of non-dipping among patients with essential hypertension
2 the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean
3 the lacking information on the administration-time dependent effects on BP of ramipril a widely used ACEI in doses of 5-10 mgday
Detailed Description:
Several attributes of the cardiovascular system including blood pressure BP and heart rate HR are characterized by predictable changes during the 24 hours for the most part in synchrony with the rest-activity cycle During the past two decades specific features of the 24-hour BP pattern have been assessed as potential sources of injury to target tissues and as triggers of cardiac and cerebrovascular events in hypertensive patients A growing number of studies indicate the reduction of the normal 10 to 20 sleep-time BP decline non-dipper pattern is associated with elevated risk of end-organ injury particularly to the heart left ventricular hypertrophy and myocardial infarct brain stoke and kidney albuminuria and progression to end-stage renal failure Accordingly there is growing interest in how to tailor the treatment of hypertensive patients according to their circadian BP pattern
Clinical studies demonstrated a different effect of the ACEIs benazepril enalapril perindopril quinapril spirapril and trandolapril when dosed in the morning versus the evening A small trial on 33 patients with essential hypertension showed that a low dose of 25 mgday ramipril more effectively reduced daytime BP when it was administered in the morning and more effectively reduced nighttime BP when it was administered in the evening In the HOPE Heart Outcomes Prevention Evaluation study patients in the active treatment group received ramipril at bedtime Results from a small substudy in which hypertensive patients were evaluated with 24-hour ambulatory BP monitoring ABPM showed a marked BP reduction particularly during nighttime sleep thereby reducing the prevalence of non-dippers The authors concluded that the effects on cardiovascular morbidity and mortality seen with ramipril in the HOPE study may relate to its improved effect ie increase in the diurnalnocturnal BP ratio on the non-dipping BP patterns
In keeping with the documented administration-time dependent effects on BP regulation of other ACEI this prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mgday when administered as a monotherapy either upon awakening from nighttime sleep or at bedtime to diurnally active patients with grade 1 or 2 essential hypertension who will be evaluated by 48-hour ABPM before and after pharmacologic intervention The benefits from this trial may be extremely important taking into account 1 the high prevalence of non-dipping among patients with essential hypertension 2 the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean and 3 the lacking information on the administration-time dependent effects on BP of ramipril a widely used ACEI in doses of 5-10 mgday
Clinical studies demonstrated a different effect of the ACEIs benazepril enalapril perindopril quinapril spirapril and trandolapril when dosed in the morning versus the evening A small trial on 33 patients with essential hypertension showed that a low dose of 25 mgday ramipril more effectively reduced daytime BP when it was administered in the morning and more effectively reduced nighttime BP when it was administered in the evening In the HOPE Heart Outcomes Prevention Evaluation study patients in the active treatment group received ramipril at bedtime Results from a small substudy in which hypertensive patients were evaluated with 24-hour ambulatory BP monitoring ABPM showed a marked BP reduction particularly during nighttime sleep thereby reducing the prevalence of non-dippers The authors concluded that the effects on cardiovascular morbidity and mortality seen with ramipril in the HOPE study may relate to its improved effect ie increase in the diurnalnocturnal BP ratio on the non-dipping BP patterns
In keeping with the documented administration-time dependent effects on BP regulation of other ACEI this prospective chronotherapy trial will investigate the potential differing efficacy of ramipril in doses from 5 to 10 mgday when administered as a monotherapy either upon awakening from nighttime sleep or at bedtime to diurnally active patients with grade 1 or 2 essential hypertension who will be evaluated by 48-hour ABPM before and after pharmacologic intervention The benefits from this trial may be extremely important taking into account 1 the high prevalence of non-dipping among patients with essential hypertension 2 the need for a proper 24-hour BP control with particular emphasis on the regulation of nighttime resting BP mean and 3 the lacking information on the administration-time dependent effects on BP of ramipril a widely used ACEI in doses of 5-10 mgday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract-2006-006107-37 | None | None | None |