Arterial Hypertension
Conditions
Keywords
chlortalidone, amiloride, arterial hypertension
Brief 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.
Detailed description
To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form. Some eligibility criteria: perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram
Interventions
DRUGChlorthalidone 25 mg + amiloride hydrochloride 5 mg
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
DRUGHigroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | Visit 4 (75 ± 3 days of V1) | V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Visit 4 (75 ± 3 days of V1) | Will be considered as secondary outcomes BP \<140 X 90 mmHg after Visit 4 (75 ± 3 days of V1). V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0) |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Higroton® Chlorthalidone 25mg - one oral tablet a day in the morning
Higroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks | 121 |
| Diupress® Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks | 122 |
| Total | 243 |
Baseline characteristics
| Characteristic | Higroton® | Diupress® | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 7 | 61 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 65 Participants | 74 Participants | 139 Participants |
| Sex: Female, Male Male | 56 Participants | 48 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 121 | 55 / 122 |
| serious Total, serious adverse events | 1 / 121 | 2 / 122 |
Outcome results
Primary
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Time frame: Visit 4 (75 ± 3 days of V1)
Population: Analysis of ITT. The number of participants differed across visits due to variations in attendance.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diupress® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V1 (15 ± 3 days after V0) | 18 Participants |
| Diupress® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V2 (30 ± 3 days after V0) | 25 Participants |
| Diupress® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V3 (60 ± 3 days after V0) | 31 Participants |
| Diupress® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V4 (90 ± 3 days after V0) | 36 Participants |
| Higroton® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V4 (90 ± 3 days after V0) | 51 Participants |
| Higroton® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V1 (15 ± 3 days after V0) | 19 Participants |
| Higroton® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V3 (60 ± 3 days after V0) | 52 Participants |
| Higroton® | Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4 | V2 (30 ± 3 days after V0) | 51 Participants |
Secondary
Blood Pressure
Will be considered as secondary outcomes BP \<140 X 90 mmHg after Visit 4 (75 ± 3 days of V1). V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
Time frame: Visit 4 (75 ± 3 days of V1)
Population: ITT. The number of participants differed across visits due to variations in attendance.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Diupress® | Blood Pressure | V1 Delta diastolic blood pressure | 79.63 mmHg | Standard Deviation 10.46 |
| Diupress® | Blood Pressure | V1 delta systolic blood pressure | 130.52 mmHg | Standard Deviation 15.7 |
| Diupress® | Blood Pressure | V4 delta diastolic blood pressure | 74.63 mmHg | Standard Deviation 8.73 |
| Diupress® | Blood Pressure | V4 delta systolic blood pressure | 120.64 mmHg | Standard Deviation 11.73 |
| Higroton® | Blood Pressure | V4 delta diastolic blood pressure | 75.24 mmHg | Standard Deviation 9.68 |
| Higroton® | Blood Pressure | V1 Delta diastolic blood pressure | 79.08 mmHg | Standard Deviation 9.5 |
| Higroton® | Blood Pressure | V4 delta systolic blood pressure | 124.05 mmHg | Standard Deviation 13.09 |
| Higroton® | Blood Pressure | V1 delta systolic blood pressure | 131.06 mmHg | Standard Deviation 13.07 |