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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400777
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : June 18, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan, hydrochlorothiazide and amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,

Secondary Outcome Measures :
  1. Mean change from study baseline in Diastolic Blood Pressure and in Systolic Blood Pressure after 4, 8 and 12 weeks of treatment
  2. Mean change from study baseline in standing diastolic and systolic blood pressure after 4, 8 and 12 weeks of treatment
  3. Safety and tolerability of the valsartan/HCTZ/amlodipine treatment algorithm strategy after 4, 8 and 12 weeks of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400777

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Rio de Janeiro, Brazil, RJ 20551-030
Sponsors and Collaborators
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Study Chair: Novartis AG Sponsor GmbH

Layout table for additonal information Identifier: NCT00400777    
Other Study ID Numbers: CVEA489ABR01
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: June 2008
Keywords provided by Novartis:
high blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Natriuretic Agents
Sodium Chloride Symporter Inhibitors