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Trial record 23 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients

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ClinicalTrials.gov Identifier: NCT00240448
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 5, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 14, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE September 2003
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00240448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients
Official Title  ICMJE A Randomised, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of MICARDIS® HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus DIOVAN® HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and Stage 2 Hypertension
Brief Summary The primary objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: telmisartan 80 mg/hydrochlorothiazide 25 mg
  • Drug: valsartan 160 mg/hydrochlorothiazide 25 mg
  • Drug: placebo
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: November 4, 2013)
1109
Original Enrollment  ICMJE
 (submitted: October 14, 2005)
1035
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Ability to provide written informed consent.
  2. Age 18 years or older.
  3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion).
  4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline).

Exclusion criteria

  1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:

    • Are not surgically sterile and/or
    • Are nursing or pregnant
    • Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
  2. Known or suspected secondary hypertension.
  3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
  4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
    • Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.
  5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
  6. Clinically relevant hypokalemia or hyperkalemia.
  7. Uncorrected volume depletion.
  8. Uncorrected sodium depletion.
  9. Primary aldosteronism.
  10. Hereditary fructose intolerance.
  11. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
  12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
  13. History of drug or alcohol dependency within six months prior to start of run-in period.
  14. Chronic administration of any medications known to affect blood pressure, etc.
  15. Any investigational drug therapy within one month of start of run-in period.
  16. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
  17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
  18. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
  19. Night shift workers.
  20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
  21. NYHA functional class CHF III-IV.
  22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.
  24. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
  25. History of non-compliance with prescribed medication or protocol procedures.
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 NCT00240448
Other Study ID Numbers  ICMJE 502.421
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 November 2013

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