Clinical trial NCT00274638: PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)
Official title: A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.


Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent in accordance with GCP and local legislation.
2. Mild-to-moderate hypertension defined as a mean seated DBP of \>= 95 mm Hg and \<=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
3. Male or Female \>= 18 years.
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
5. 24-hour ABPM mean DBP of \>= 85 mm Hg at Visit 3.

Exclusion Criteria:

1. Pre-menopausal women (last menstruation \<= 1 year prior to signing informed consent) who

   * are not surgically sterile, or are
   * nursing, or
   * 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 IUD, oral, implantable or injectable contraceptives. No exception will be made.
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
3. Mean seated SBP \>= 180 mm Hg or mean seated DBP \>= 110 mm Hg during any visit or the placebo run-in phase.
4. Known or suspected secondary hypertension (i.e. pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (\>203 mico mol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Biliary obstructive disorders.
8. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
9. Uncorrected volume depletion.
10. Primary aldosteronism.
11. Hereditary fructose intolerance.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past 3 months prior to signing the informed consent form.
14. Stroke within the past 6 months prior to signing the informed consent form.
15. Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
16. PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.
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, hemodynamically 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 3 months as defined by an HbA1C \>= 10 Percent.
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 signing the informed consent form.
22. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational therapy within 1 month of signing the informed consent form.
24. Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
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. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
27. History of non-compliance with prescribed medication.
28. Inability to comply with protocol.

Primary outcomes:
measure: Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring)
timeFrame: after 6 Weeks
Secondary outcomes:
measure: Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP)
timeFrame: after 6 weeks
measure: Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP
timeFrame: after 6 weeks
measure: Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval
timeFrame: after 6 weeks
measure: Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval
timeFrame: after 6 weeks
measure: Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer
timeFrame: after 6 weeks
measure: Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements
timeFrame: after 6 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Research Solutions, LLC
state: Arkansas
city: Carmichael
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Concord
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Fresno
country: United States
facility: Sierra Medical Research
state: California
city: Long Beach
country: United States
facility: Attn: Ginger Paselk
state: California
city: Orangevale
country: United States
facility: DeBruin Medical Center
state: California
city: Orange
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Dr. R. David Ferrera
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
state: Colorado
city: Trumbull
country: United States
facility: Clinical Research Consultants, Inc.
state: Connecticut
city: Newark
country: United States
facility: Glasgow Family Pract6ice
state: Delaware
city: Coral Gables
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Miami Research Associates
state: Florida
city: Hollywood
country: United States
facility: Patron, Andres, D.O.
state: Florida
city: Kissimmee
country: United States
facility: Christopher Chappel, MD
state: Florida
city: Melbourne
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: Attention: Larry I. Gilderman, D.O.
state: Florida
city: St. Petersburg
country: United States
facility: nTouch Research
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Research Associates
state: Florida
city: Augusta
country: United States
facility: Southern Clinical Research and Management, Inc.
state: Georgia
city: Conyers
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Cardiology
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Herron Medical Center, Ltd.
state: Illinois
city: Elk Grove Village
country: United States
facility: Protococare Trials, Inc.
state: Illinois
city: Peoria
country: United States
facility: N Touch Research
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research Inc.
state: Indiana
city: Overland
country: United States
facility: Radiant Research
state: Kansas
city: Oxon Hill
country: United States
facility: Ong Medical Center
state: Maryland
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: St. Paul
country: United States
facility: Cardiology Research
state: Minnesota
city: Florissant
country: United States
facility: Attention: Mel E. Lucas, DO
state: Missouri
city: Alburquerque
country: United States
facility: New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
state: New Mexico
city: Syracuse
country: United States
facility: Syracuse Preventative Cardiology
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Williamsville
country: United States
facility: Cardiology and Internal Medicine- Williamsville NY
state: New York
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: North Carolina
city: Charlotte
country: United States
facility: Bennett Cardiac Center
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: nTouch Research Corporation
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Research Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Reseach
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Oklahoma City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: nTouch
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Collegeville
country: United States
facility: Bock Clinical Research
state: Pennsylvania
city: Downingtown
country: United States
facility: Bock Clinical Research
state: Pennsylvania
city: Harleysville
country: United States
facility: Bock Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Research
state: Rhode Island
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Veterans Affairs Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: nTouch Research
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Medical Specialists
state: Virginia
city: Norfolk
country: United States
facility: 885 Kempsville Road, Suite 221
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Madison
country: United States
facility: Gemini Scientific
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: