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

Novartis

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Valsartan, hydrochlorothiazide and amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00400777

CVEA489ABR01

Details and patient eligibility

About

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.

Enrollment

460 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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