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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)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00274638
Collaborator
(none)
805
Enrollment
69
Locations
11.7
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Telmisartan & Hydrochlorothiazide
  • Drug: Losartan & Hydrochlorothiazide
  • Procedure: ABPM
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
805 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Jul 1, 2003

Outcome Measures

Primary Outcome Measures

  1. 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) [after 6 Weeks]

Secondary Outcome Measures

  1. Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP) [after 6 weeks]

  2. Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP [after 6 weeks]

  3. Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval [after 6 weeks]

  4. Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval [after 6 weeks]

  5. Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer [after 6 weeks]

  6. Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements [after 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.

  2. Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.

  3. Known or suspected secondary hypertension (i.e. pheochromocytoma).

  4. 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).

  5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.

  6. Biliary obstructive disorders.

  7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.

  8. Uncorrected volume depletion.

  9. Primary aldosteronism.

  10. Hereditary fructose intolerance.

  11. Congestive heart failure (NYHA functional class CHF III-IV).

  12. Unstable angina within the past 3 months prior to signing the informed consent form.

  13. Stroke within the past 6 months prior to signing the informed consent form.

  14. Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.

  15. PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.

  16. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.

  17. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.

  18. 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.

  19. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.

  20. History of drug or alcohol dependency within 6 months prior to signing the informed consent form.

  21. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.

  22. Any investigational therapy within 1 month of signing the informed consent form.

  23. Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).

  24. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.

  25. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).

  26. History of non-compliance with prescribed medication.

  27. Inability to comply with protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boehringer Ingelheim Investigational Site Huntsville Alabama United States
2 Research Solutions, LLC Little Rock Arkansas United States
3 Boehringer Ingelheim Investigational Site Carmichael California United States
4 Boehringer Ingelheim Investigational Site Concord California United States
5 Sierra Medical Research Fresno California United States
6 Attn: Ginger Paselk Long Beach California United States
7 DeBruin Medical Center Orangevale California United States
8 Boehringer Ingelheim Investigational Site Orange California United States
9 Clinical Trials Research Roseville California United States
10 Dr. R. David Ferrera Sacramento California United States
11 Westlake Medical Research Westlake Village California United States
12 Rocky Mountain Pulmonary & Critical Care Medicine, Inc. Wheat Ridge Colorado United States
13 Clinical Research Consultants, Inc. Trumbull Connecticut United States
14 Glasgow Family Pract6ice Newark Delaware United States
15 Boehringer Ingelheim Investigational Site Coral Gables Florida United States
16 Miami Research Associates Coral Gables Florida United States
17 Patron, Andres, D.O. Hollywood Florida United States
18 Christopher Chappel, MD Kissimmee Florida United States
19 Boehringer Ingelheim Investigational Site Melbourne Florida United States
20 Orlando Clinical Research Center Orlando Florida United States
21 Attention: Larry I. Gilderman, D.O. Pembroke Pines Florida United States
22 nTouch Research St. Petersburg Florida United States
23 Tampa Medical Research Associates Tampa Florida United States
24 Southern Clinical Research and Management, Inc. Augusta Georgia United States
25 Boehringer Ingelheim Investigational Site Conyers Georgia United States
26 Treasure Valley Cardiology Boise Idaho United States
27 Cedar-Crosse Research Center Chicago Illinois United States
28 Herron Medical Center, Ltd. Chicago Illinois United States
29 Protococare Trials, Inc. Elk Grove Village Illinois United States
30 N Touch Research Peoria Illinois United States
31 Midwest Institute for Clinical Research Inc. Indianapolis Indiana United States
32 Radiant Research Overland Kansas United States
33 Ong Medical Center Oxon Hill Maryland United States
34 Radiant Research Edina Minnesota United States
35 Cardiology Research St. Paul Minnesota United States
36 Attention: Mel E. Lucas, DO Florissant Missouri United States
37 New Mexico Clinical Reaearch & Osteoporosis Center, Inc. Alburquerque New Mexico United States
38 Syracuse Preventative Cardiology Syracuse New York United States
39 Great Lakes Medical Research Westfield New York United States
40 Cardiology and Internal Medicine- Williamsville NY Williamsville New York United States
41 Comprehensive Clinical Research Berlin North Carolina United States
42 Bennett Cardiac Center Charlotte North Carolina United States
43 Charlotte Clinical Research Charlotte North Carolina United States
44 Boehringer Ingelheim Investigational Site Raleigh North Carolina United States
45 nTouch Research Corporation Raleigh North Carolina United States
46 Piedmont Research Associates Winston Salem North Carolina United States
47 Wake Forest University School of Medicine Winston Salem North Carolina United States
48 Boehringer Ingelheim Investigational Site Cincinnati Ohio United States
49 Radiant Reseach Cincinnati Ohio United States
50 Radiant Research Columbus Ohio United States
51 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma United States
52 nTouch Oklahoma City Oklahoma United States
53 Hillcrest Medical Center Tulsa Oklahoma United States
54 Bock Clinical Research Collegeville Pennsylvania United States
55 Bock Clinical Research Downingtown Pennsylvania United States
56 Bock Clinical Research Harleysville Pennsylvania United States
57 The Western Pennsylvania Hospital Pittsburgh Pennsylvania United States
58 Omega Research Warwick Rhode Island United States
59 University of Tennessee Medical Center Knoxville Tennessee United States
60 Veterans Affairs Medical Center Memphis Tennessee United States
61 Clinical Research Associates, Inc. Nashville Tennessee United States
62 Boehringer Ingelheim Investigational Site Dallas Texas United States
63 nTouch Research Houston Texas United States
64 Hampton Roads Medical Specialists Hampton Virginia United States
65 885 Kempsville Road, Suite 221 Norfolk Virginia United States
66 York Clinical Research Norfolk Virginia United States
67 Boehringer Ingelheim Investigational Site Richmond Virginia United States
68 Gemini Scientific Madison Wisconsin United States
69 University of Wisconsin Medical School Madison Wisconsin United States

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00274638
Other Study ID Numbers:
  • 502.387
First Posted:
Jan 11, 2006
Last Update Posted:
Dec 9, 2013
Last Verified:
Dec 1, 2013
Additional relevant MeSH terms:
Hypertension
Losartan
Hydrochlorothiazide
Telmisartan

Study Results

No Results Posted as of Dec 9, 2013