Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
This study has been completed.
Study NCT00437645   Information provided by Novartis
First Received: February 16, 2007   Last Updated: January 27, 2009   History of Changes

February 16, 2007
January 27, 2009
January 2007
November 2007   (final data collection date for primary outcome measure)
  • Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]
  • Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]
  • Change in mean sitting systolic blood pressure (MSSBP) after 8-week treatment
  • Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema after 8-week treatment
Complete list of historical versions of study NCT00437645 on ClinicalTrials.gov Archive Site
  • Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline in MSSBP and MSDBP [ Time Frame: after 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change in mean sitting diastolic blood pressure (MSDBP) after 8-week treatment
  • Change from baseline in MSSBP and MSDBP after 4 and 12 weeks of treatment
  • Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) at week 4, 8, and 12
  • Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) at week 4, 8, and 12
  • Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) at week 4, 8, and 12
 
Safety and Efficacy of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
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

This study is 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 will evaluate the efficacy and tolerability of both treatment groups by providing data evaluating blood pressure lowering efficacy and the proportion of patients developing peripheral edema.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Essential Hypertension
  • Drug: Valsartan/Amlodipine
  • Drug: Amlodipine
 
Schrader J, Salvetti A, Calvo C, Akpinar E, Keeling L, Weisskopf M, Brunel P. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg. Int J Clin Pract. 2009 Feb;63(2):217-25.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1183
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients &#8805; 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 &#8805;&#61472;140 mmHg and &#8804; 160 mmHg
  • Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP &#8804; 160 mmHg
  • To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP &#8805;&#61472;130 mmHg and &#8804; 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 randomization
  • MSSBP >180mmHg 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany
 
NCT00437645
Novartis Pharmaceuticals, External Affairs
CVAA489A2404
Novartis Pharmaceuticals
 
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP