Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 116 for:    Atenolol

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00687973
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : January 21, 2011
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE March 20, 2008
First Posted Date  ICMJE June 2, 2008
Results First Submitted Date  ICMJE December 22, 2010
Results First Posted Date  ICMJE January 21, 2011
Last Update Posted Date March 11, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
central SBP measured at carotid artery level ( assessed with Sphygmocor system, Atcor Medical, Sydney, Australia) : difference in reduction of central SBP at baseline and at 24 weeks between the two arms [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT00687973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
  • Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) [ Time Frame: Baseline and Week 8 ]
  • Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline of Augmentation Index (Aix) at Week 8 [ Time Frame: Baseline and Week 8 ]
    To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
  • Change From Baseline of Aix at Week 24 [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline of Aix Corrected to Heart Rate at Week 24 [ Time Frame: Baseline and Week 24 ]
    The heart rate correction was computed by a multivariate model analysis
  • Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ]
    Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
  • Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline of SBP/DBP at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ]
  • Change From Baseline of Pulse Pressure at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
central pressure assessed with Sphygmocor system (Atcor Medical, Sydney, Australia) [ Time Frame: Baseline, 8 weeks, 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Official Title  ICMJE Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Brief Summary Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Valsartan/amlodipine 80/5 mg tablets
  • Drug: Amlodipine 5 mg capsules
  • Drug: Amlodipine 10 mg capsules
  • Drug: Atenolol 50 mg tablets
  • Drug: Atenolol 100 mg tablets
Study Arms  ICMJE
  • Experimental: Valsartan/amlodipine 160/10 mg
    Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
    Intervention: Drug: Valsartan/amlodipine 80/5 mg tablets
  • Active Comparator: Atenolol/amlodipine 100/10 mg
    Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
    Interventions:
    • Drug: Amlodipine 5 mg capsules
    • Drug: Amlodipine 10 mg capsules
    • Drug: Atenolol 50 mg tablets
    • Drug: Atenolol 100 mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2011)
393
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2008)
398
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients 18 years of age or older
  • Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
  • Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

  • Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
  • Evidence of a secondary form of hypertension
  • Type 1 diabetes mellitus
  • History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00687973
Other Study ID Numbers  ICMJE CVAA489AFR02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2011

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