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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)

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ClinicalTrials.gov Identifier: NCT00274638
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : December 9, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE January 10, 2006
First Posted Date  ICMJE January 11, 2006
Last Update Posted Date December 9, 2013
Study Start Date  ICMJE July 2002
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
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
Change History Complete list of historical versions of study NCT00274638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP) [ Time Frame: after 6 weeks ]
  • Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP [ Time Frame: after 6 weeks ]
  • 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 ]
  • 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 ]
  • Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer [ Time Frame: after 6 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Telmisartan & Hydrochlorothiazide
  • Drug: Losartan & Hydrochlorothiazide
  • Procedure: ABPM
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2013)
805
Original Enrollment  ICMJE
 (submitted: January 10, 2006)
810
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00274638
Other Study ID Numbers  ICMJE 502.387
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2013

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