Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM (PRISMA)
This study has been completed.
Information provided by:
Boehringer Ingelheim Pharmaceuticals
First received: January 10, 2006
Last updated: October 31, 2013
Last verified: October 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||November 2003 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 24-hour mean DBP of greater than or equal to 85 mmHg at Visit 3 as measured by ABPM.
- Age 18 years or older.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- Ability to provide written informed consent in accordance with GCP and local legislation.
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.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- 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.
- Known or suspected secondary hypertension (i.e., pheochromocytoma).
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).
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
- Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Biliary obstructive disorders.
- Congestive heart failure (NYHA functional class CHF III-IV).
- Unstable angina within the past three months prior to start of run in period.
- Stroke within the past six months prior to start of run in period.
- Myocardial infarction or cardiac surgery within the past three months prior to start of run in period.
- PTCA (percutaneous transluminal coronary angioplasty) within the past three months prior to start of run in period.
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve.
- 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%.
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- History of drug or alcohol dependency within 6 months prior to start of run in period.
- Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol.
- Any investigational therapy within one month of start of run in period.
- Known hypersensitivity to any component of the formulations.
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- Inability to comply with the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274612
Boehringer Ingelheim Pharmaceuticals
||Boehringer Ingelheim Study Coordinator
||Boehringer Ingelheim Ltd./Bracknell
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 10, 2006
||October 31, 2013
||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)
South Africa: Medicines Control Council
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 19, 2013
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists