Phase 3
Completed N=243
Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension
Source: ClinicalTrials.gov NCT01191450 ↗Enrolled (actual)
243
Serious AEs
1.2%
Results posted
Jun 2025
Primary outcomePrimary: Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 — 18; 19; 25; 51 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 |
18; 19; 25; 51; 31; 52 | — |
| SECONDARY Blood Pressure |
130.52; 131.06; 120.64; 124.05; 79.63; 79.08 | — |
Eligibility Criteria
Inclusion Criteria
- Systolic blood pressure between 140 mmHg - 159 mmHg
- Diastolic blood pressure between 90 mmHg - 99 mmHg
- Subject aged ≥ 60 years old
- Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.
- Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.
Exclusion Criteria
- Any serious or severe clinically significant medical condition.
- Psychiatric or neurological diseases
- A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.
- Participation in any other investigational study within 12 months prior to Visit 1.
- Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study
- Routine prior use of diuretics
- Oral anticoagulant use
- Fast glycemia > 150 mg/dL
- Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up.
- Expected onset of additional antihypertensive drug after the study onset
- Acute myocardial infarction within last 6 months
- Prior decompensated coronary artery disease
- Known thyroid, renal or liver dysfunction, at investigator's discretion
- Obesity - body mass index (BMI) > 33 kg/m2
Data sourced from ClinicalTrials.gov (NCT01191450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.