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Comparison · NCT01885559-sae

ACE-I + Placebo vs ACE-I + ARB: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. ACE-I + Placebo vs ACE-I + ARB: serious adverse events. Trial comparisons, record NCT01885559-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01885559-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3640.3060.426wilson
Risk in group 20.3610.3030.423wilson
Risk difference, group 1 minus group 20.00298-0.08190.0879newcombe hybrid score
Risk ratio, group 1 over group 21.010.7961.28log
Odds ratio, group 1 over group 21.010.71.47log
Number needed to harm, for one more participant with a serious adverse event on ACE-I + Placebo than on ACE-I + ARB336from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1ACE-I + Placebo
ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
88242EG000
Group 2ACE-I + ARB
ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
88244EG001

Harm

What it counts
Total, serious adverse events
Time frame
Serious adverse event data were collected during follow up between 5-8 years with average follow up time of 5.2 years.

Source ClinicalTrials.gov

Trial

Title
HALT Progression of Polycystic Kidney Disease Study B
NCT number
NCT01885559
Phases
PHASE3
Conditions
Kidney, Polycystic
Interventions
Lisinopril, Telmisartan, Placebo
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results first posted
2015-03-10

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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