Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM
NCT ID: NCT00274612
Last Updated: 2013-11-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
801 participants
Study Classification
INTERVENTIONAL
Study Start Date
2002-10-31
Study Completion Date
2003-11-30
Brief Summary
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The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of an 8 and 14-week treatment period, respectively.
Detailed Description
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Secondary objectives will compare telmisartan (80 mg) (MICARDIS® and ramipril (5 mg and 10 mg) on: 1) the reduction in the last 6-hour ABPM mean pulse pressure (PP) relative to dosing, 2) the reductions in the 24-hour ABPM mean DBP, SBP and PP relative to dosing, 3) reductions in ABPM mean DBP, SBP and PP during other periods of the 24-hour dosing interval (i.e., morning, daytime, and nighttime) relative to clock time, 4) change from baseline in systolic and diastolic blood pressure load during the 24-hour dosing interval, 5) reductions in the mean seated trough DBP and SBP measured using a manual in-clinic cuff sphygmomanometer, 6) responder rates as determined by both ABPM and manual in-clinic cuff measurements and 7) Health-Related Quality of Life (HRQL).
Study Hypothesis:
It is hypothesised that the rise of blood pressure (BP) during the last hours of the sleeping period is a cause of the high incidence of cardiovascular events in the morning. The purpose of the present study is to demonstrate that telmisartan (MICARDIS®) is not inferior to ramipril in lowering blood pressure in patients with mild-to-moderate hypertension. Blood pressure will be assessed by ambulatory blood pressure monitoring (ABPM) as this will allow comparison of the full 24-hour effects of both treatments without artefacts (e.g., white-coat hypertension) introduced by measurement of blood pressure in the clinic. This will measure diastolic blood pressures over the entire 24-hour dosing interval, with primary attention focused on the last six hours of the dosing interval.
NULL AND ALTERNATIVE HYPOTHESES In order to test the multiple hypotheses (e.g., non-inferiority and superiority of telmisartan compared to ramipril), multiple dosages (i.e., telmisartan 80mg (MICARDIS®) versus ramipril 5mg and ramipril 10mg after 8 and 14 weeks of treatment, respectively), and the two endpoints (i.e., reduction in DBP and SBP during the last 6 hours of the 24-hour dosing interval) as measured by ABPM, a completely hierarchical, closed testing procedure will be used.
Hierarchical Closed Testing Procedure:
1. Non-inferiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8 week treatment period in the reduction of DBP during the last 6 hours of the 24 hour dosing interval; if significant then,
2. Superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8-week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; if significant then,
3. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8-week treatment period in the reduction of SBP during the last 6 hours of the 24-hour dosing interval; if significant then,
4. Non-inferiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10 mg at the end of an 14 week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; if significant then,
5. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10 mg at the end of an 14-week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; and if significant then,
6. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10mg at the end of an 14-week treatment period in the reduction of SBP during the last 6 hours of the 24-hour dosing interval.
A difference of 2 mmHg was determined to be the maximum difference between the mean reductions in DBP during the last 6 hours of the 24-hour dosing interval for the two treatments which would be considered to have no clinical importance (i.e., the limit for non inferiority). Thus non-inferiority of telmisartan compared to ramipril will be tested using the following set of hypotheses:
Null Hypothesis:
The overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan 80 mg (MICARDIS®) is inferior to that for ramipril by at least 2 mmHg.
Alternative Hypothesis: The overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is less than 2 mmHg smaller than that for ramipril.
These hypotheses can be stated as:
H0: dT - dR less than or equal to -2 mmHg versus HA: dT - dR \> -2 mmHg where dT and dR represent the overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan and ramipril, respectively, adjusted for any other factors included in the statistical model.
If the lower limit of the two-sided 95% confidence interval for the difference between the least square means of both treatments (telmisartan - ramipril) lies above -2 mmHg, then it will be concluded that telmisartan 80mg (MICARDIS®) is at least as effective as ramipril (5mg after 8 weeks of treatment or 10mg after 14 weeks of treatment, depending upon the comparison) in reducing DBP during the last 6 hours of the 24-hour dosing interval.
Superiority of telmisartan (MICARDIS®) compared to ramipril will be tested using the following set of hypotheses:
Null Hypothesis:
The overall mean reduction from baseline in the ABPM mean during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is less than or equal to that for ramipril.
Alternative Hypothesis: The overall mean reduction from baseline in the ABPM mean during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is greater than that for ramipril.
These hypotheses can be stated as:
H0: dT - dR less than or equal to 0 mmHg versus HA: dT - dR \> 0 mmHg where dT and dR represent the overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan and ramipril, respectively, adjusted for any other factors included in the statistical model.
If the lower limit of the two-sided 95% confidence interval for the difference between the least square means of both treatments (telmisartan (MICARDIS®) - ramipril) is greater than zero, then it will be concluded that telmisartan 80mg (MICARDIS®) is statistically superior to ramipril (5mg after 8 weeks of treatment or 10mg after 14 weeks of treatment, depending upon the comparison) in reducing blood pressure (DBP or SBP, depending upon the comparison) during the last 6 hours of the 24-hour dosing interval.
Comparison(s):
Reductions in blood pressure during the last 6 hours of the 24-hour dosing interval as measured by ABPM in patients treated with telmisartan (MICARDIS®) compared to patients treated with ramipril. The primary analysis will consist of a closed testing procedure first testing for non-inferiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10mg after fourteen weeks of treatment in the reduction in diastolic blood pressure (DBP); if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 10 mg in the reduction in DBP; if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 10 mg in the reduction of systolic blood pressure (SBP); if significant, testing for non-inferiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg after eight weeks of treatment in the reduction in DBP; if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg in the reduction in DBP; and if significant, testing for superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 5mg in the reduction in SBP.
Study Hypothesis:
It is hypothesised that the rise of blood pressure (BP) during the last hours of the sleeping period is a cause of the high incidence of cardiovascular events in the morning. The purpose of the present study is to demonstrate that telmisartan (MICARDIS®) is not inferior to ramipril in lowering blood pressure in patients with mild-to-moderate hypertension. Blood pressure will be assessed by ambulatory blood pressure monitoring (ABPM) as this will allow comparison of the full 24-hour effects of both treatments without artefacts (e.g., white-coat hypertension) introduced by measurement of blood pressure in the clinic. This will measure diastolic blood pressures over the entire 24-hour dosing interval, with primary attention focused on the last six hours of the dosing interval.
NULL AND ALTERNATIVE HYPOTHESES In order to test the multiple hypotheses (e.g., non-inferiority and superiority of telmisartan compared to ramipril), multiple dosages (i.e., telmisartan 80mg (MICARDIS®) versus ramipril 5mg and ramipril 10mg after 8 and 14 weeks of treatment, respectively), and the two endpoints (i.e., reduction in DBP and SBP during the last 6 hours of the 24-hour dosing interval) as measured by ABPM, a completely hierarchical, closed testing procedure will be used.
Hierarchical Closed Testing Procedure:
1. Non-inferiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8 week treatment period in the reduction of DBP during the last 6 hours of the 24 hour dosing interval; if significant then,
2. Superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8-week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; if significant then,
3. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 5 mg at the end of the 8-week treatment period in the reduction of SBP during the last 6 hours of the 24-hour dosing interval; if significant then,
4. Non-inferiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10 mg at the end of an 14 week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; if significant then,
5. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10 mg at the end of an 14-week treatment period in the reduction of DBP during the last 6 hours of the 24-hour dosing interval; and if significant then,
6. Superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10mg at the end of an 14-week treatment period in the reduction of SBP during the last 6 hours of the 24-hour dosing interval.
A difference of 2 mmHg was determined to be the maximum difference between the mean reductions in DBP during the last 6 hours of the 24-hour dosing interval for the two treatments which would be considered to have no clinical importance (i.e., the limit for non inferiority). Thus non-inferiority of telmisartan compared to ramipril will be tested using the following set of hypotheses:
Null Hypothesis:
The overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan 80 mg (MICARDIS®) is inferior to that for ramipril by at least 2 mmHg.
Alternative Hypothesis: The overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is less than 2 mmHg smaller than that for ramipril.
These hypotheses can be stated as:
H0: dT - dR less than or equal to -2 mmHg versus HA: dT - dR \> -2 mmHg where dT and dR represent the overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan and ramipril, respectively, adjusted for any other factors included in the statistical model.
If the lower limit of the two-sided 95% confidence interval for the difference between the least square means of both treatments (telmisartan - ramipril) lies above -2 mmHg, then it will be concluded that telmisartan 80mg (MICARDIS®) is at least as effective as ramipril (5mg after 8 weeks of treatment or 10mg after 14 weeks of treatment, depending upon the comparison) in reducing DBP during the last 6 hours of the 24-hour dosing interval.
Superiority of telmisartan (MICARDIS®) compared to ramipril will be tested using the following set of hypotheses:
Null Hypothesis:
The overall mean reduction from baseline in the ABPM mean during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is less than or equal to that for ramipril.
Alternative Hypothesis: The overall mean reduction from baseline in the ABPM mean during the last 6 hours of the 24-hour dosing interval for telmisartan 80mg (MICARDIS®) is greater than that for ramipril.
These hypotheses can be stated as:
H0: dT - dR less than or equal to 0 mmHg versus HA: dT - dR \> 0 mmHg where dT and dR represent the overall mean reduction from baseline in ABPM mean DBP during the last 6 hours of the 24-hour dosing interval for telmisartan and ramipril, respectively, adjusted for any other factors included in the statistical model.
If the lower limit of the two-sided 95% confidence interval for the difference between the least square means of both treatments (telmisartan (MICARDIS®) - ramipril) is greater than zero, then it will be concluded that telmisartan 80mg (MICARDIS®) is statistically superior to ramipril (5mg after 8 weeks of treatment or 10mg after 14 weeks of treatment, depending upon the comparison) in reducing blood pressure (DBP or SBP, depending upon the comparison) during the last 6 hours of the 24-hour dosing interval.
Comparison(s):
Reductions in blood pressure during the last 6 hours of the 24-hour dosing interval as measured by ABPM in patients treated with telmisartan (MICARDIS®) compared to patients treated with ramipril. The primary analysis will consist of a closed testing procedure first testing for non-inferiority of telmisartan 80mg (MICARDIS®) compared to ramipril 10mg after fourteen weeks of treatment in the reduction in diastolic blood pressure (DBP); if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 10 mg in the reduction in DBP; if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 10 mg in the reduction of systolic blood pressure (SBP); if significant, testing for non-inferiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg after eight weeks of treatment in the reduction in DBP; if significant, testing for superiority of telmisartan 80 mg (MICARDIS®) compared to ramipril 5 mg in the reduction in DBP; and if significant, testing for superiority of telmisartan 80mg (MICARDIS®) compared to ramipril 5mg in the reduction in SBP.
Conditions
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Hypertension
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Telmisartan
Intervention Type
DRUG
Ramipril
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of greater than or equal to 95 mmHg and less than or equal to 109 mmHg, measured by manual cuff sphygmomanometer at Visit 2.
2. 24-hour mean DBP of greater than or equal to 85 mmHg at Visit 3 as measured by ABPM.
3. Age 18 years or older.
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
5. Ability to provide written informed consent in accordance with GCP and local legislation.
2. 24-hour mean DBP of greater than or equal to 85 mmHg at Visit 3 as measured by ABPM.
3. Age 18 years or older.
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
5. Ability to provide written informed consent in accordance with GCP and local legislation.
Exclusion Criteria
1. Pre-menopausal women (last menstruation approximately less than or equal to 1 year prior to signing informed consent) who:
* Are not surgically sterile
* Are nursing,
* Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intra uterine device, oral, implantable or injectable contraceptives.
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
3. Mean sitting SBP greater than or equal to180 mmHg or mean sitting DBP greater than or equal to 110 mmHg during any visit of the placebo run-in period.
4. Known or suspected secondary hypertension (i.e., pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range.
* Serum creatinine \> 2.3mg/dL (or \> 203 micromol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past three months prior to start of run in period.
14. Stroke within the past six months prior to start of run in period.
15. Myocardial infarction or cardiac surgery within the past three months prior to start of run in period.
16. PTCA (percutaneous transluminal coronary angioplasty) within the past three months prior to start of run in period.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve.
19. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C greater than or equal to 10%.
20. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
21. History of drug or alcohol dependency within 6 months prior to start of run in period.
22. Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational therapy within one month of start of run in period.
24. Known hypersensitivity to any component of the formulations.
25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
26. Inability to comply with the protocol.
* Are not surgically sterile
* Are nursing,
* Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intra uterine device, oral, implantable or injectable contraceptives.
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
3. Mean sitting SBP greater than or equal to180 mmHg or mean sitting DBP greater than or equal to 110 mmHg during any visit of the placebo run-in period.
4. Known or suspected secondary hypertension (i.e., pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range.
* Serum creatinine \> 2.3mg/dL (or \> 203 micromol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past three months prior to start of run in period.
14. Stroke within the past six months prior to start of run in period.
15. Myocardial infarction or cardiac surgery within the past three months prior to start of run in period.
16. PTCA (percutaneous transluminal coronary angioplasty) within the past three months prior to start of run in period.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve.
19. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C greater than or equal to 10%.
20. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
21. History of drug or alcohol dependency within 6 months prior to start of run in period.
22. Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational therapy within one month of start of run in period.
24. Known hypersensitivity to any component of the formulations.
25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
26. Inability to comply with the protocol.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim Ltd./Bracknell
Locations
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Rehabilitationszentrum für Herz- und Kreislauferkrankungen
Bad Tatzmannsdorf, , Austria
Site Status
A.ö. Landeskrankenhaus Bruck a. d. Mur
Bruck A. D. Mur, , Austria
Site Status
Landeskrankenhaus Graz West
Graz, , Austria
Site Status
Medizinische Universitätsklinik Graz
Graz, , Austria
Site Status
Univ.-Klinik für Innere Medizin III
Vienna, , Austria
Site Status
Landeskrankenhaus Villach
Villach, , Austria
Site Status
Boehringer Ingelheim Investigational Site
Angers, , France
Site Status
Boehringer Ingelheim Investigational Site
Angers, , France
Site Status
Hôpital Saint André
Bordeaux, , France
Site Status
Boehringer Ingelheim Investigational Site
Laval, , France
Site Status
Boehringer Ingelheim Investigational Site
Mayenne, , France
Site Status
Boehringer Ingelheim Investigational Site
Saint Laurent Du Medoc, , France
Site Status
Boehringer Ingelheim Investigational Site
Saumur, , France
Site Status
Boehringer Ingelheim Investigational Site
Gaggenau, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Haag, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Linkenheim-Hochstetten, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Mühldorf, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Plattling, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Unterschneidheim, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Villingen-Schwenningen, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Vilsbiburg, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Westerkappeln, , Germany
Site Status
Boehringer Ingelheim Investigational Site
Bennebroek, , Netherlands
Site Status
Boehringer Ingelheim Investigational Site
Heerlen, , Netherlands
Site Status
Boehringer Ingelheim Investigational Site
Nijverdal, , Netherlands
Site Status
Boehringer Ingelheim Investigational Site
Rotterdam, , Netherlands
Site Status
Boehringer Ingelheim Investigational Site
Bellville, , South Africa
Site Status
Health Emporium
Midrand, , South Africa
Site Status
Boehringer Ingelheim Investigational Site
Vanderbijlpark, , South Africa
Site Status
1 Military Hospital
Vootrekkehoogte, , South Africa
Site Status
Boehringer Ingelheim Investigational Site
Barcelona, , Spain
Site Status
Hospital de Galdakao
Galdakao / Vizcaya, , Spain
Site Status
Pabellon de Consultas
Madrid, , Spain
Site Status
Edificio de Consultas Externas
Oviedo, , Spain
Site Status
Boehringer Ingelheim Investigational Site
Salamanca, , Spain
Site Status
Pabellon B / 1 piso
Santa Coloma de Gramanet, , Spain
Site Status
Centro de Diagnostico y Tratamiento
Seville, , Spain
Site Status
Universitätsspital Basel
Basel, , Switzerland
Site Status
Boehringer Ingelheim Investigational Site
Basel, , Switzerland
Site Status
Schweizerisches Herz- und Gefässzentrum
Bern, , Switzerland
Site Status
Cardiocentro Ticino
Lugano, , Switzerland
Site Status
Boehringer Ingelheim Investigational Site
Muralto, , Switzerland
Site Status
Boehringer Ingelheim Investigational Site
Münsterlingen, , Switzerland
Site Status
Boehringer Ingelheim Investigational Site
Ashford, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Atherstone, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Bath, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Bedworth, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Coventry, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Doncaster, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Fowey, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Frome, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Glasgow, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Ilford, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Lesley, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Lostwithiel, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Royal Leamington Spa, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Ryde, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Trowbridge, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Wells Next to the Sea, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Whitstable, , United Kingdom
Site Status
Boehringer Ingelheim Investigational Site
Whitstable, , United Kingdom
Site Status
York District Hospital
York, , United Kingdom
Site Status
Countries
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Austria
France
Germany
Netherlands
South Africa
Spain
Switzerland
United Kingdom
Other Identifiers
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502.391
Identifier Type: -
Identifier Source: org_study_id