HypertensionPhase 4NCT00302705
Comparison of the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose
A Phase 4 study testing Valsartan, Enalapril, Ambulatory blood pressure monitoring and Missing one dose in people with Hypertension, run by University of Vigo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan, Enalapril, Ambulatory blood pressure monitoring and Missing one dose
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension (grade 1-2)
Who cannot join
- 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
Show all 9Show fewer
- History of malignancy.
- shift workers
- intolerant to ABPM
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
About this 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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Valsartan, Enalapril, Ambulatory blood pressure monitoring, Missing one dose
- Keywords
- Ambulatory blood pressure monitoring, Valsartan, Enalapril, Missing dose
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan, EnalaprilDrug
160 mg valsartan versus 10-20 mg enalapril
Ambulatory blood pressure monitoringDevice
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
Missing one doseProcedure or surgery
Patients skip the dose the second day of monitoring
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Active comparator | 160 mg/day on awakening Receives: Drug: Valsartan, Enalapril; Device: Ambulatory blood pressure monitoring; Procedure: Missing one dose |
| Enalapril | Active comparator | 10-20 mg/day on awakening Receives: Drug: Valsartan, Enalapril; Device: Ambulatory blood pressure monitoring; Procedure: Missing one dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of valsartan by testing the hypothesis of superior 24 hrs diastolic BP lowering after missing dose compared with enalapril.
Measured: 16 weeks
Secondary outcomes (4)
To demonstrate that valsartan is more effective than enalapril in terms of systolic 24 hrs BP lowering after missing dose.
Measured: 16 weeks
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.
Measured: 16 weeks
To show that valsartan has a more favorable effect than enalapril in smoothness index and through/peak ratio.
Measured: 16 weeks
To demonstrate that valsartan offers better safety profile than enalapril.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario de Santiago, Novartis
- Investigators
- Ramon C Hermida, Ph.D., Principal investigator, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302705
- Sponsor's protocol ID
- VAL-489A2425
- Other IDs
- 2004-001725-25, 2004
- Status last verified
- Jan 2009
- First submitted
- 13 Mar 2006
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hermida RC, Ayala DE, Khder Y, Calvo C. Ambulatory blood pressure-lowering effects of valsartan and enalapril after a missed dose in previously untreated patients with hypertension: a prospective, randomized, open-label, blinded end-point trial. Clin Ther. 2008 Jan;30(1):108-20. doi: 10.1016/j.clinthera.2008.01.012.
PubMed 18343247
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00302705
- Acronym / sponsor ID
- VAL-489A2425
- Conditions
- Hypertension
- Keywords
- Ambulatory blood pressure monitoring, Valsartan, Enalapril, Missing dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Hospital Clinico Universitario de Santiago, Novartis
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Active comparator | Drug: Valsartan, Enalapril, Device: Ambulatory blood pressure monitoring, Procedure: Missing one dose160 mg/day on awakening |
| Enalapril | Active comparator | Drug: Valsartan, Enalapril, Device: Ambulatory blood pressure monitoring, Procedure: Missing one dose10-20 mg/day on awakening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Essential hypertension (grade 1-2)
Key exclusion criteria (9 listed)
- Severe hypertension
- Secondary hypertension
- Grade III/IV hypertensive retinopathy
- Type 1 diabetes
- Cerebrovascular or cardiovascular event during the last 12 months prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan, Enalapril160 mg valsartan versus 10-20 mg enalapril | Drug | Enalapril, Valsartan |
| Ambulatory blood pressure monitoringBlood pressure measured at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours | Device | Enalapril, Valsartan |
| Missing one dosePatients skip the dose the second day of monitoring | Procedure or surgery | Enalapril, Valsartan |
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.
Time frame: 16 weeks
4 secondary outcomes
To demonstrate that valsartan is more effective than enalapril in terms of systolic 24 hrs BP lowering after missing dose.
Time frame: 16 weeks
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.
Time frame: 16 weeks
To show that valsartan has a more favorable effect than enalapril in smoothness index and through/peak ratio.
Time frame: 16 weeks
To demonstrate that valsartan offers better safety profile than enalapril.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
- Derived from this study: PubMed 18343247Hermida RC, Ayala DE, Khder Y, Calvo C. Ambulatory blood pressure-lowering effects of valsartan and enalapril after a missed dose in previously untreated patients with hypertension: a prospective, randomized, open-label, blinded end-point trial. Clin Ther. 2008 Jan;30(1):108-20. doi: 10.1016/j.clinthera.2008.01.012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon C Hermida, Ph.D. principal investigator
University of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan, Enalapril, Ambulatory blood pressure monitoring and Missing one dose in people with Hypertension, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the efficacy of valsartan by testing the hypothesis of superior 24 hrs diastolic BP lowering after missing dose compared with enalapril. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2009.