Comparison · NCT04692467-fc49aa41
Intervention (Early Hypertension) vs Standard of Care: Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intervention (Early Hypertension) vs Standard of Care: Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related. Trial comparisons, record NCT04692467-fc49aa41. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04692467-fc49aa41
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0645 | 0.0331 | 0.122 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000173 | 0.0296 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0645 | 0.0213 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Intervention (Early Hypertension) than on Standard of Care | 15.5 | 8.19 | 46.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention (Early Hypertension) | Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \>130 mmHg after 1 month.~Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group. | 8 | 124 | OG000 |
| Group 2 | Standard of Care | Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg). | 0 | 126 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
- Description
- Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
- Time frame
- Followup month 2
- Population
Source ClinicalTrials.gov
Trial
- Title
- Treatment of Early Hypertension Among Persons Living With HIV in Haiti
- NCT number
- NCT04692467
- Phases
- PHASE2
- Conditions
- HIV/AIDS, Pre Hypertension
- Interventions
- Amlodipine 5mg
- Lead sponsor
- Weill Medical College of Cornell University
- Results first posted
- 2024-04-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04692467?tab=results
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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