Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM (PRISMA)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274612
First received: January 10, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Telmisartan
Drug: Ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5--10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring. PRISMA = Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in the last 6-hour mean (relative to dose time) diastolic and systolic blood pressure (DBP and SBP) as measured by ABPM [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the last 6-hour ABPM mean (relative to dosing time) for pulse pressure (PP) [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Changes in the 24-hour ABPM mean (relative to dosing time) for DBP, SBP and PP [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Changes in the ABPM mean (relative to clock-time) for DBP, SBP and PP during the morning, daytime and night-time periods of the 24-hour dosing interval. [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Changes in SBP and DBP load during the 24-hour dosing interval [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Changes in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Responder rates based on both the 24-hour ABPM mean (relative to dose time) BPs and manual in-clinic trough cuff measurements [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in patient Health Related Quality of Life (HRQL) as measured by Psychological General Wellbeing Index (PGWB). [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • Manually triggered BP measurements before going to bed and upon arising in the morning [ Time Frame: after 8 and 14 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 801
Study Start Date: October 2002
Estimated Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274612

  Hide Study Locations
Locations
Austria
Rehabilitationszentrum für Herz- und Kreislauferkrankungen
Bad Tatzmannsdorf, Austria, 7431
A.ö. Landeskrankenhaus Bruck a. d. Mur
Bruck a. d. Mur, Austria, 8600
Landeskrankenhaus Graz West
Graz, Austria, 8020
Medizinische Universitätsklinik Graz
Graz, Austria, 8036
Landeskrankenhaus Villach
Villach, Austria, 9500
Univ.-Klinik für Innere Medizin III
Wien, Austria, 1090
France
Boehringer Ingelheim Investigational Site
Angers, France, 49100
Boehringer Ingelheim Investigational Site
Angers, France, 49000
Hôpital Saint André
Bordeaux cedex, France, 33075
Boehringer Ingelheim Investigational Site
Laval, France, 53000
Boehringer Ingelheim Investigational Site
Mayenne, France, 53100
Boehringer Ingelheim Investigational Site
Saint Laurent du Medoc, France, 33112
Boehringer Ingelheim Investigational Site
Saumur, France, 49400
Germany
Boehringer Ingelheim Investigational Site
Gaggenau, Germany, 76571
Boehringer Ingelheim Investigational Site
Haag, Germany, 83527
Boehringer Ingelheim Investigational Site
Linkenheim-Hochstetten, Germany, 76351
Boehringer Ingelheim Investigational Site
Mühldorf am Inn, Germany, 84453
Boehringer Ingelheim Investigational Site
Plattling, Germany, 94447
Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany, 73485
Boehringer Ingelheim Investigational Site
Villingen-Schwenningen, Germany, 78054
Boehringer Ingelheim Investigational Site
Vilsbiburg, Germany, 84137
Boehringer Ingelheim Investigational Site
Westerkappeln, Germany, 49492
Netherlands
Boehringer Ingelheim Investigational Site
Bennebroek, Netherlands, 2121 BB
Boehringer Ingelheim Investigational Site
Heerlen, Netherlands, 6415 HT
Boehringer Ingelheim Investigational Site
Nijverdal, Netherlands, 7441 BN
Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands, 3082 DC
South Africa
Boehringer Ingelheim Investigational Site
Bellville, South Africa, 7531
Health Emporium
Midrand, South Africa, 1685
Boehringer Ingelheim Investigational Site
Vanderbijlpark, South Africa, 1911
1 Military Hospital
Vootrekkehoogte, South Africa, 0143
Spain
Boehringer Ingelheim Investigational Site
Barcelona, Spain, 08003
Hospital de Galdakao
Galdakao / Vizcaya, Spain, 48680
Pabellon de Consultas
Madrid, Spain, 28007
Edificio de Consultas Externas
Oviedo, Spain, 33006
Boehringer Ingelheim Investigational Site
Salamanca, Spain, 37007
Centro de Diagnostico y Tratamiento
Sevilla, Spain, 41013
Pabellon B / 1 piso
Sta Coloma de Gramanet, Spain, 08923
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Boehringer Ingelheim Investigational Site
Basel, Switzerland, 4055
Schweizerisches Herz- und Gefässzentrum
Bern, Switzerland, 3010
Cardiocentro Ticino
Lugano, Switzerland, 6900
Boehringer Ingelheim Investigational Site
Muralto, Switzerland, 6600
Boehringer Ingelheim Investigational Site
Münsterlingen, Switzerland, 8596
United Kingdom
Boehringer Ingelheim Investigational Site
Ashford, United Kingdom, TW15 3EA
Boehringer Ingelheim Investigational Site
Atherstone, United Kingdom, CV9 1EU
Boehringer Ingelheim Investigational Site
Bath, United Kingdom, BA2 3HAT
Boehringer Ingelheim Investigational Site
Bedworth, United Kingdom, CV6 4DD
Boehringer Ingelheim Investigational Site
Coventry, United Kingdom, CV7 8LA
Boehringer Ingelheim Investigational Site
Doncaster, United Kingdom, DN1 2EG
Boehringer Ingelheim Investigational Site
Fowey, United Kingdom, PL23 1DT
Boehringer Ingelheim Investigational Site
Frome, United Kingdom, BA11 2QE
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G69 7AD
Boehringer Ingelheim Investigational Site
Ilford, United Kingdom, IG3 8BG
Boehringer Ingelheim Investigational Site
Leamington Spa, United Kingdom, CV32 4RA
Boehringer Ingelheim Investigational Site
Lesley, United Kingdom, KY6 3LG
Boehringer Ingelheim Investigational Site
Lostwithiel, United Kingdom, PL22 0EF
Boehringer Ingelheim Investigational Site
Ryde, United Kingdom, PO33 2PT
Boehringer Ingelheim Investigational Site
Trowbridge, United Kingdom, BA14 7EG
Boehringer Ingelheim Investigational Site
Wells Next to the Sea, United Kingdom, NR23 1JP
Boehringer Ingelheim Investigational Site
Whitstable, United Kingdom, CT5 1BZ
Boehringer Ingelheim Investigational Site
Whitstable, United Kingdom, CT5 3QU
York District Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274612     History of Changes
Other Study ID Numbers: 502.391
Study First Received: January 10, 2006
Last Updated: October 31, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Bundesministerium f. Gesundheit und Frauen Sektion III - Gesundheitswesen
Germany: Bundesinstitute für Arzneimittel und Medizinprodukte
Spain: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medical Ethics Review Committee (METC)
Switzerland: Swissmedic
South Africa: Medicines Control Council

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Telmisartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 24, 2014