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:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274638
First received: January 10, 2006
Last updated: December 6, 2013
Last verified: December 2013

January 10, 2006
December 6, 2013
July 2002
July 2003   (final data collection date for primary outcome 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) [ Time Frame: after 6 Weeks ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00274638 on ClinicalTrials.gov Archive Site
  • Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP) [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
  • Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
  • Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
  • Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
  • Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
  • Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
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)
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Telmisartan & Hydrochlorothiazide
  • Drug: Losartan & Hydrochlorothiazide
  • Procedure: ABPM
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
805
Not Provided
July 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274638
502.387
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP