Status:
COMPLETED
Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Essential Hypertension
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequatel...
Eligibility Criteria
Inclusion
- Male or female outpatients ≥ 55 years of age
- Patients with essential hypertension measured using a validated automated oscillometric device at Visit 1
- Non-treated patients must have a MSSBP ≥ 140 mmHg and ≤ 160 mmHg
- Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP ≤ 160 mmHg
- To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP ≥ 130 mmHg and ≤ 160 mmHg
- No peripheral edema at Visit 2 (randomization)
- Written informed consent to participate in this study prior to any study procedures
Exclusion
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
- Patients taking more than 1 antihypertensive medication at Visit 1
- Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization
- msSBP \> 180 mmHg or msDBP \> 110 mmHg at any time between Visit 1 and Visit 2
- Evidence of a secondary form of hypertension, including but not limited to any of the following: Coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma
- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
- History of heart failure Grade II - IV according to the NYHA classification
- Second or third degree heart block with or without a pacemaker
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- Concomitant unstable angina pectoris
- Clinically significant valvular heart disease
- Patients with Type 1 diabetes mellitus
- Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator's judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1
- Evidence of hepatic disease as determined by one of the following: AST or ALT values \> 2x UNL at study entry, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
- Evidence of renal impairment as determined by one of the following: serum creatinine \> 1.5 x UNL at visit 1, history of dialysis, or history of nephrotic syndrome
- Serum potassium values \> 5.5 mmol/L at study entry
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Any surgical or medical condition which, at the discretion of the investigator or Novartis medical monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study period
- Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
- Any severe, life-threatening disease within the past five years
- History of drug or alcohol abuse within the last 2 years
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent
- Persons directly involved in the execution of this protocol
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
1183 Patients enrolled
Trial Details
Trial ID
NCT00437645
Start Date
January 1 2007
End Date
November 1 2007
Last Update
November 11 2014
Active Locations (12)
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1
sites in Argentina
Agentina, Argentina
2
sites in Chile
Chile, Chile
3
sites in Ecuador
Ecuador, Ecuador
4
sites in Finland
Finland, Finland