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

NCT00400777 | Completed Phase 4

• 1 other identifier: CVEA489ABR01
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Valsartan; hydrochlorothiazide; amlodipine; hypertension; high blood pressure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,

Secondary Outcomes (3)

• 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

Interventions

Valsartan, hydrochlorothiazide and amlodipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Rio de Janeiro, RJ 20551-030, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines

Study Officials

• Novartis AG

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: June 18, 2008

Record last verified: 2008-06

Locations

BR (1)