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Trial record 28 of 100 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension

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ClinicalTrials.gov Identifier: NCT00400777
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : June 18, 2008
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE November 15, 2006
First Posted Date  ICMJE November 17, 2006
Last Update Posted Date June 18, 2008
Study Start Date  ICMJE August 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00400777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
  • Mean change from study baseline in Diastolic Blood Pressure and in Systolic Blood Pressure after 4, 8 and 12 weeks of treatment
  • Mean change from study baseline in standing diastolic and systolic blood pressure after 4, 8 and 12 weeks of treatment
  • Safety and tolerability of the valsartan/HCTZ/amlodipine treatment algorithm strategy after 4, 8 and 12 weeks of treatment
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 Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension
Official Title  ICMJE An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide
Brief Summary This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.
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: Valsartan, hydrochlorothiazide and amlodipine
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
Estimated Enrollment  ICMJE
 (submitted: November 15, 2006)
460
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients ≥18 years of age
  • Patients treated with up to two high blood pressure medications in a stable dose considered adequate by the investigator, for a minimum of two months, with blood pressure not controlled according to the following criteria:
  • Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg for low risk patients (no known target organ damage and without risk factor or presenting 1 - except Type 2 diabetes mellitus - risk factor);
  • Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥85 mmHg for medium risk patients (no known target organ damage and 2 or more risk factors - except Type 2 diabetes mellitus);
  • Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥80 mmHg for high risk patients (known target organ damage, and/or Type 2 diabetic patients and/or any clinically identifiable cardiovascular disease). OR
  • Systolic Blood Pressure ≥160 mmHg and/or Diastolic Blood Pressure ≥100 mmHg at Visits 1 and 2 for previously untreated patients
  • Patients previously treated but who stopped their medications will be considered untreated after one month without treatment
  • Obs: -The target organ are: Brain, Heart, Kidney, Retina.
  • The risk factors are: Smoking, Dyslipidemia, Age > 60 years old, and Family history of cardiovascular diseases (women < 65 years old and men < 55 years old

Exclusion Criteria:

  • Systolic Blood Pressure ≥180 mmHg and/or Diastolic Blood Pressure ≥110 mmHg at Visit 1 or Visit 2
  • Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
  • Known Keith-Wagener grade III or IV hypertensive retinopathy
  • History of hypertensive encephalopathy
  • Cerebrovascular accident or myocardial infarction 12 months prior to Visit 1
  • History of transient ischemic attack 12 months prior to Visit 1
  • Percutaneous coronary intervention or coronary artery bypass graft surgery 12 months prior to Visit 1
  • Diabetes mellitus type 1
  • Diabetes mellitus type 2 under insulin treatment
  • Poorly controlled type 2 diabetes mellitus
  • History of heart failure Grade II - IV according to the NYHA classification
  • Second or third degree heart block without a pacemaker
  • Concomitant unstable angina pectoris
  • Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
  • Clinically significant valvular heart disease
  • Women of child-bearing potential
  • Pregnant or nursing (lactating) women
  • Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
  • Additional protocol-defined inclusion/exclusion criteria may apply
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 Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00400777
Other Study ID Numbers  ICMJE CVEA489ABR01
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 Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis AG Sponsor GmbH
PRS Account Novartis
Verification Date June 2008

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