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Clinical Trials/EUCTR2006-004586-34-FR
EUCTR2006-004586-34-FR
Active, not recruiting
Not Applicable

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

ovartis Pharma Services AG0 sites1,018 target enrollmentStarted: November 30, 2006Last updated:
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DrugsDiovanNorvasc

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,018
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1\.Male or female outpatients \= 55 years of age
  • •2\.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
  • •3\.To be eligible for randomization at Visit 2 (Day 1\) all patients must have a MSSBP \=?130 mmHg and \= 160 mmHg
  • •4\.No peripheral edema at Visit 2 (randomization)
  • •5\.Written informed consent to participate in this study prior to any study procedures
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\.Women of child\-bearing potential, defined as all women physiologically capable of becoming pregnant
  • •2\.Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
  • •3\.Patients taking more than 1 antihypertensive medication at Visit 1
  • •4\.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
  • •5\.MSSBP \> 180mmHg or MSDBP ? 110 mmHg at any time between Visit 1 and Visit 2
  • •6\.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
  • •7\.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
  • •8\.History of heart failure Grade II \- IV according to the NYHA classification
  • •9\.Second or third degree heart block with or without a pacemaker
  • •10\.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia

Investigators

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