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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170950
First received: September 10, 2005
Last updated: April 19, 2011
Last verified: April 2011
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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 |
| Total | Total of all reporting groups |
Baseline Measures
| Benazepril/Amlodipine | Benazepril/Hydrochlorothiazide | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
5744 | 5761 | 11505 |
|
Age
[1] [units: Years] Mean ± Standard Deviation |
68.4 ± 6.86 | 68.3 ± 6.86 | 68.4 ± 6.86 |
|
Gender
[1] [units: Participants] |
|||
| Female | 2296 | 2246 | 4542 |
| Male | 3448 | 3515 | 6963 |
| [1] | Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available. |
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Outcome Measures
| 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
| Time Frame | Double-blind period |
|---|---|
| Additional Description | Safety population includes all randomized patients who took at least one dose of study medication by actual treatment group (7 Benazepril / Amlodipine and 2 Benazepril / HCTZ patients did not take study medication; 3 patients assigned to Benazepril / HCTZ received Benazepril / Amlodipine medication instead). |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
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Reporting Groups
| Description | |
|---|---|
| Benazepril / Amlodipine | Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily |
| Benazepril / HCTZ | Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily |
Other Adverse Events
| Benazepril / Amlodipine | Benazepril / HCTZ | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 3077/5740 | 2663/5757 |
| General disorders | ||
| Oedema peripheral † 1 | ||
| # participants affected / at risk | 1787/5740 (31.13%) | 768/5757 (13.34%) |
| Nervous system disorders | ||
| Dizziness † 1 | ||
| # participants affected / at risk | 1175/5740 (20.47%) | 1440/5757 (25.01%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough † 1 | ||
| # participants affected / at risk | 1172/5740 (20.42%) | 1217/5757 (21.14%) |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA |