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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00400777
First received: November 15, 2006
Last updated: June 17, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Hypertension
Drug: Valsartan, hydrochlorothiazide and amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 460
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: November 2007 (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:

  • 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
  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: NCT00400777

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

No publications provided

ClinicalTrials.gov Identifier: NCT00400777     History of Changes
Other Study ID Numbers: CVEA489ABR01
Study First Received: November 15, 2006
Last Updated: June 17, 2008
Health Authority: Brazil: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
Valsartan
hydrochlorothiazide
amlodipine
hypertension
high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Amlodipine
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
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 24, 2014