Status:
COMPLETED
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Lead Sponsor:
Novartis
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg...
Eligibility Criteria
Inclusion
- Patients must give written informed consent
- Male or female ages 18 or older and less than 86 years
- Diagnosed as having essential diastolic hypertension, as follows:
- Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and \< 100 mmHg
- At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP \>=90 mmHg and \<110 mmHg
Exclusion
- Severe hypertension
- Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
- Malignant hypertension
- Administration of any agent indicated for the treatment of hypertension after Visit 1
- Known moderate or malignant retinopathy.
- Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
- History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
- History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
- Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
932 Patients enrolled
Trial Details
Trial ID
NCT01001572
Start Date
September 1 2009
End Date
May 1 2010
Last Update
May 24 2011
Active Locations (2)
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1
Investigative site in Romainia
2
Novartis Investigative Site