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
  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: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 805
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274638

  Show 69 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274638     History of Changes
Other Study ID Numbers: 502.387
Study First Received: January 10, 2006
Last Updated: December 6, 2013
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 July 23, 2014