Clinical trial NCT00274599: PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN
Official title: A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 812
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg \& 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.


Eligibility criteria: Inclusion criteria:

* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
* Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥95 mmHg and ≤109 mmHg, measured by manual cuff sphygmomanometer at Visit 2.
* Age 18 years or older (or 19 years if dictated by local State/Province policies).
* Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
* 24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Exclusion criteria:

* Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:

  * were not surgically sterile; or
  * were nursing, or
  * were of childbearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included IUD, oral, implantable or injectable contraceptives. No exceptions were made.
* Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m.
* Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period.
* Known or suspected secondary hypertension (e.g., phaeochromocytoma).
* Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) \>2 times the upper limit of normal range, or
* Serum creatinine \>2.3 mg/dL (or \>203 μmol/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.
* Further exclusion criteria apply

Primary outcomes:
measure: Change from baseline in the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg)
timeFrame: Up to week 14
Secondary outcomes:
measure: Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytime and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff
timeFrame: Up to week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Harold B. Betton, M.D.
state: Arkansas
city: Long Beach
country: United States
facility: Attn: Ginger Paselk
state: California
city: Los Angeles
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Orange
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Vista
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Hamden
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Daytona Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Marietta
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Orland Park
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GFI Pharmaceuticals
state: Indiana
city: Newton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Metairie
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maine
city: Moorestown
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Mexico
city: East Syracuse
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: White Plains
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oregon
city: Levittown
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Lacey
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: West Virginia
city: Calgary
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Alberta
city: Conquitlam
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: British Columbia
city: Riverview
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: New Brunswick
city: St. John
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Exeter
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Hastings
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: North York
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Orleans
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: 205-13085 Yonge St
state: Ontario
city: St. Catharines
country: Canada
facility: 155 Ontario Street
state: Ontario
city: Thunder Bay
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Winnipeg
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Granby
country: Canada
facility: 4 rue Robinson Nord
state: Quebec
city: Longueuil
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: St Leonard
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Val D'Or
country: Canada
facility: 725 6E Rue
state: Quebec
city: Regina
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Saskatchewan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: