Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH)

This study has been terminated.
(The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170950
First received: September 10, 2005
Last updated: April 19, 2011
Last verified: April 2011
Results First Received: January 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1
Drug: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2
Drug: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter
Drug: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1
Drug: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2
Drug: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Benazepril/Amlodipine Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
Benazepril/Hydrochlorothiazide Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily

Participant Flow:   Overall Study
    Benazepril/Amlodipine     Benazepril/Hydrochlorothiazide  
STARTED     5744     5762  
COMPLETED     4859     4852  
NOT COMPLETED     885     910  
Death                 236                 274  
Withdrawal by Subject                 496                 498  
Lost to Follow-up                 134                 115  
Missing                 2                 1  
Termination Data Not Recorded                 17                 22  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event   [ Time Frame: For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]

2.  Secondary:   Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event   [ Time Frame: For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])] ]

3.  Secondary:   Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke   [ Time Frame: For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was stopped early, as recommended by the Data Monitoring Committee, due to positive efficacy results.


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