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)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00274638
First received: January 10, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan & Hydrochlorothiazide Drug: Losartan & Hydrochlorothiazide Procedure: ABPM |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PROBE Parallel Group 6 wk Treatment Comparing Telmisartan + HCT (40/12.5mg, or 80/12.5mg) With Losartan + HCT (50/12.5mg) Using ABPM in Pts With Mild-to Moderate Hypertension |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering DBP during the last 6 hrs of the 24-hr dosing interval in mild-mod hypertensives at the end of a 6-w [ Time Frame: 6 Weeks ]
Secondary Outcome Measures:
- Compared MICARDIS® HCT with Hyzaar® at the end of 6 wks treatment in the reduction of SBP during the last 6 hrs of the 24-hr dosing interval; also in 24-hr ABPM mean DBP and SBP; reductions in ABPM mean DBP & SBP (morn, day & night); manual cuff reading [ Time Frame: 6 Weeks ]
| Estimated Enrollment: | 810 |
| Study Start Date: | July 2002 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to provide written informed consent in accordance with GCP and local legislation.
- 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.
- Male or Female >= 18 years.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- 24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.
Exclusion Criteria:
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.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
- Known or suspected secondary hypertension (i.e. pheochromocytoma).
- 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).
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
- Biliary obstructive disorders.
- Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Congestive heart failure (NYHA functional class CHF III-IV).
- Unstable angina within the past 3 months prior to signing the informed consent form.
- Stroke within the past 6 months prior to signing the informed consent form.
- Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
- PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically 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 3 months as defined by an HbA1C >= 10 Percent.
- 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 signing the informed consent form.
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
- Any investigational therapy within 1 month of signing the informed consent form.
- Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
- History of non-compliance with prescribed medication.
- Inability to comply with protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274638
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Hide Study LocationsLocations
| United States, Alabama | |
| Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| United States, Arkansas | |
| Research Solutions, LLC | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Boehringer Ingelheim Investigational Site | |
| Carmichael, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Concord, California, United States | |
| Sierra Medical Research | |
| Fresno, California, United States | |
| Attn: Ginger Paselk | |
| Long Beach, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Orange, California, United States | |
| DeBruin Medical Center | |
| Orangevale, California, United States | |
| Clinical Trials Research | |
| Roseville, California, United States | |
| Dr. R. David Ferrera | |
| Sacramento, California, United States | |
| Westlake Medical Research | |
| Westlake Village, California, United States | |
| United States, Colorado | |
| Rocky Mountain Pulmonary & Critical Care Medicine, Inc. | |
| Wheat Ridge, Colorado, United States | |
| United States, Connecticut | |
| Clinical Research Consultants, Inc. | |
| Trumbull, Connecticut, United States | |
| United States, Delaware | |
| Glasgow Family Pract6ice | |
| Newark, Delaware, United States | |
| United States, Florida | |
| Miami Research Associates | |
| Coral Gables, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Coral Gables, Florida, United States | |
| Patron, Andres, D.O. | |
| Hollywood, Florida, United States | |
| Christopher Chappel, MD | |
| Kissimmee, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Melbourne, Florida, United States | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States | |
| Attention: Larry I. Gilderman, D.O. | |
| Pembroke Pines, Florida, United States | |
| nTouch Research | |
| St. Petersburg, Florida, United States | |
| Tampa Medical Research Associates | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Southern Clinical Research and Management, Inc. | |
| Augusta, Georgia, United States | |
| Boehringer Ingelheim Investigational Site | |
| Conyers, Georgia, United States | |
| United States, Idaho | |
| Treasure Valley Cardiology | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| Cedar-Crosse Research Center | |
| Chicago, Illinois, United States | |
| Herron Medical Center, Ltd. | |
| Chicago, Illinois, United States | |
| Protococare Trials, Inc. | |
| Elk Grove Village, Illinois, United States | |
| N Touch Research | |
| Peoria, Illinois, United States | |
| United States, Indiana | |
| Midwest Institute for Clinical Research Inc. | |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| Radiant Research | |
| Overland, Kansas, United States | |
| United States, Maryland | |
| Ong Medical Center | |
| Oxon Hill, Maryland, United States | |
| United States, Minnesota | |
| Radiant Research | |
| Edina, Minnesota, United States | |
| Cardiology Research | |
| St. Paul, Minnesota, United States | |
| United States, Missouri | |
| Attention: Mel E. Lucas, DO | |
| Florissant, Missouri, United States | |
| United States, New Mexico | |
| New Mexico Clinical Reaearch & Osteoporosis Center, Inc. | |
| Alburquerque, New Mexico, United States | |
| United States, New York | |
| Syracuse Preventative Cardiology | |
| Syracuse, New York, United States | |
| Great Lakes Medical Research | |
| Westfield, New York, United States | |
| Cardiology and Internal Medicine- Williamsville NY | |
| Williamsville, New York, United States | |
| United States, North Carolina | |
| Comprehensive Clinical Research | |
| Berlin, North Carolina, United States | |
| Charlotte Clinical Research | |
| Charlotte, North Carolina, United States | |
| Bennett Cardiac Center | |
| Charlotte, North Carolina, United States | |
| nTouch Research Corporation | |
| Raleigh, North Carolina, United States | |
| Boehringer Ingelheim Investigational Site | |
| Raleigh, North Carolina, United States | |
| Wake Forest University School of Medicine | |
| Winston Salem, North Carolina, United States | |
| Piedmont Research Associates | |
| Winston Salem, North Carolina, United States | |
| United States, Ohio | |
| Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| Radiant Reseach | |
| Cincinnati, Ohio, United States | |
| Radiant Research | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| nTouch | |
| Oklahoma City, Oklahoma, United States | |
| Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| Hillcrest Medical Center | |
| Tulsa, Oklahoma, United States | |
| United States, Pennsylvania | |
| Bock Clinical Research | |
| Collegeville, Pennsylvania, United States | |
| Bock Clinical Research | |
| Downingtown, Pennsylvania, United States | |
| Bock Clinical Research | |
| Harleysville, Pennsylvania, United States | |
| The Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Rhode Island | |
| Omega Research | |
| Warwick, Rhode Island, United States | |
| United States, Tennessee | |
| University of Tennessee Medical Center | |
| Knoxville, Tennessee, United States | |
| Veterans Affairs Medical Center | |
| Memphis, Tennessee, United States | |
| Clinical Research Associates, Inc. | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| nTouch Research | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Hampton Roads Medical Specialists | |
| Hampton, Virginia, United States | |
| York Clinical Research | |
| Norfolk, Virginia, United States | |
| 885 Kempsville Road, Suite 221 | |
| Norfolk, Virginia, United States | |
| Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
| United States, Wisconsin | |
| University of Wisconsin Medical School | |
| Madison, Wisconsin, United States | |
| Gemini Scientific | |
| Madison, Wisconsin, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274638 History of Changes |
| Other Study ID Numbers: | 502.387 |
| Study First Received: | January 10, 2006 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Losartan Telmisartan Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013