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

NCT00274612 | Completed Phase 4

• 1 other identifier: 502.391
• Study Type: interventional
• Target: 801
• Locations: 8 countries
• Sites: 62

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in the last 6-hour mean (relative to dose time) diastolic and systolic blood pressure (DBP and SBP) as measured by ABPM

  after 8 and 14 weeks

Secondary Outcomes (9)

• Changes in the last 6-hour ABPM mean (relative to dosing time) for pulse pressure (PP)

  after 8 and 14 weeks

• Changes in the 24-hour ABPM mean (relative to dosing time) for DBP, SBP and PP

  after 8 and 14 weeks

• 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.

  after 8 and 14 weeks

• Changes in SBP and DBP load during the 24-hour dosing interval

  after 8 and 14 weeks

• Changes in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer

  after 8 and 14 weeks

Interventions

Telmisartan DRUG

Ramipril DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (62)

Rehabilitationszentrum für Herz- und Kreislauferkrankungen

Bad Tatzmannsdorf, 7431, Austria

Location

A.ö. Landeskrankenhaus Bruck a. d. Mur

Bruck A. D. Mur, 8600, Austria

Location

Landeskrankenhaus Graz West

Graz, 8020, Austria

Location

Medizinische Universitätsklinik Graz

Graz, 8036, Austria

Location

Univ.-Klinik für Innere Medizin III

Vienna, 1090, Austria

Location

Landeskrankenhaus Villach

Villach, 9500, Austria

Location

Boehringer Ingelheim Investigational Site

Angers, 49000, France

Location

Boehringer Ingelheim Investigational Site

Angers, 49100, France

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

Boehringer Ingelheim Investigational Site

Laval, 53000, France

Location

Boehringer Ingelheim Investigational Site

Mayenne, 53100, France

Location

Boehringer Ingelheim Investigational Site

Saint Laurent Du Medoc, 33112, France

Location

Boehringer Ingelheim Investigational Site

Saumur, 49400, France

Location

Boehringer Ingelheim Investigational Site

Gaggenau, 76571, Germany

Location

Boehringer Ingelheim Investigational Site

Haag, 83527, Germany

Location

Boehringer Ingelheim Investigational Site

Linkenheim-Hochstetten, 76351, Germany

Location

Boehringer Ingelheim Investigational Site

Mühldorf, 84453, Germany

Location

Boehringer Ingelheim Investigational Site

Plattling, 94447, Germany

Location

Boehringer Ingelheim Investigational Site

Unterschneidheim, 73485, Germany

Location

Boehringer Ingelheim Investigational Site

Villingen-Schwenningen, 78054, Germany

Location

Boehringer Ingelheim Investigational Site

Vilsbiburg, 84137, Germany

Location

Boehringer Ingelheim Investigational Site

Westerkappeln, 49492, Germany

Location

Boehringer Ingelheim Investigational Site

Bennebroek, 2121 BB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Heerlen, 6415 HT, Netherlands

Location

Boehringer Ingelheim Investigational Site

Nijverdal, 7441 BN, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rotterdam, 3082 DC, Netherlands

Location

Boehringer Ingelheim Investigational Site

Bellville, 7531, South Africa

Location

Health Emporium

Midrand, 1685, South Africa

Location

Boehringer Ingelheim Investigational Site

Vanderbijlpark, 1911, South Africa

Location

1 Military Hospital

Vootrekkehoogte, 0143, South Africa

Location

Boehringer Ingelheim Investigational Site

Barcelona, 08003, Spain

Location

Hospital de Galdakao

Galdakao / Vizcaya, 48680, Spain

Location

Pabellon de Consultas

Madrid, 28007, Spain

Location

Edificio de Consultas Externas

Oviedo, 33006, Spain

Location

Boehringer Ingelheim Investigational Site

Salamanca, 37007, Spain

Location

Pabellon B / 1 piso

Santa Coloma de Gramanet, 08923, Spain

Location

Centro de Diagnostico y Tratamiento

Seville, 41013, Spain

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Boehringer Ingelheim Investigational Site

Basel, 4055, Switzerland

Location

Schweizerisches Herz- und Gefässzentrum

Bern, 3010, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Boehringer Ingelheim Investigational Site

Muralto, 6600, Switzerland

Location

Boehringer Ingelheim Investigational Site

Münsterlingen, 8596, Switzerland

Location

Boehringer Ingelheim Investigational Site

Ashford, TW15 3EA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Atherstone, CV9 1EU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bath, BA2 3HAT, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bedworth, CV6 4DD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Coventry, CV7 8LA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Doncaster, DN1 2EG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Fowey, PL23 1DT, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Frome, BA11 2QE, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, G69 7AD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Ilford, IG3 8BG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Lesley, KY6 3LG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Lostwithiel, PL22 0EF, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Royal Leamington Spa, CV32 4RA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Ryde, PO33 2PT, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Trowbridge, BA14 7EG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Wells Next to the Sea, NR23 1JP, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Whitstable, CT5 1BZ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Whitstable, CT5 3QU, United Kingdom

Location

York District Hospital

York, YO31 8HE, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Ramipril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Ltd./Bracknell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: October 1, 2002
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

FR (7); AU (6); DE (9); NL (4); CH (6); GB (19); ES (7); ZA (4)