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Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Valsartan 160 mg capsules (Drug); Amlodipine 5 mg capsules (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals


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 adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

Clinical Details

Official title: A Double-blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8

Percentage of Patients With Peripheral Edema From Baseline to Week 8

Secondary outcome:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8

Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12

Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12


Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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


- 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

Locations and Contacts

sites in Argentina, Agentina, Argentina

sites in Chile, Chile, Chile

sites in Ecuador, Ecuador, Ecuador

sites in Finland, Finland, Finland

sites in France, France, France

sites in Germany, Germany, Germany

sites in Italy, Italy, Italy

sites in Norway, Norway, Norway

sites in Spain, Spain, Spain

sites in Sweden, Sweden, Sweden

sites in Switzerland, Switzerland, Switzerland

sites in Turkey, Turkey, Turkey

Additional Information

Starting date: January 2007
Last updated: November 3, 2014

Page last updated: August 23, 2015

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