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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higroton® | Active Comparator | Chlorthalidone 25mg - one oral tablet a day in the morning |
|
| Diupress® | Experimental | Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorthalidone 25 mg + amiloride hydrochloride 5 mg | Drug | Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Visit 4 (75 ± 3 days of V1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Visit 4 (75 ± 3 days of V1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulo Guilherme O Silva | Hospital Santa Marcelina | Principal Investigator |
| Humberto Freitas | Hospital São Camilo | Principal Investigator |
| Jose Carlos A Ayob | Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares | Principal Investigator |
| Roberto Jorge S Franco | Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP | Principal Investigator |
| Fernando Augusto A Costa | FGM - Clínica Paulista de Doenças Cardiovasculares | Principal Investigator |
| Adriana C Forti | Centro de Estudos de Diabetes e Hipertensão | Principal Investigator |
| Paulo Cesar V Jardim | Liga de Hipertensão Arterial - Universidade Federal de Goiás | Principal Investigator |
| Marise L Castro | IMA - Instituto de Medicina Avançada | Principal Investigator |
| Daniela G Barbieri | CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Estudos de Diabetes e Hipertensão | Fortaleza | Ceará | Brazil | |||
| CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Diupress® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Higroton® Laboratório Novartis | Drug | Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks |
|
| Principal Investigator |
| Fábio José C Fucci | Instituto de Moléstias Cardiovasculares de Tatuí | Principal Investigator |
| Vitória |
| Espírito Santo |
| Brazil |
| Liga de Hipertensão Arterial - Universidade Federal de Goiás | Goiânia | Goiás | Brazil |
| UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP | Botucatu | São Paulo | Brazil |
| Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares | São José do Rio Preto | São Paulo | Brazil |
| Instituto de Moléstias Cardiovasculares de Tatuí | Tatuí | São Paulo | Brazil |
| Clínica Paulista de Doenças Cardiovasculares - FGM | São Paulo | Brazil |
| Hospital Santa Marcelina | São Paulo | Brazil |
| Hospital São Camilo | São Paulo | Brazil |
| IMA - Instituto de Medicina Avançada | São Paulo | Brazil |
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
| ITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Analysis of ITT. The number of participants differed across visits due to variations in attendance. | Posted | Count of Participants | Participants | Visit 4 (75 ± 3 days of V1) |
|
|
| |||||||||||||||||||||||||||||
| 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) | ITT. The number of participants differed across visits due to variations in attendance. | Posted | Median | Standard Deviation | mmHg | Visit 4 (75 ± 3 days of V1) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 121 | 41 | 121 | ||
| EG001 | 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 | 2 | 122 | 55 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | Myocardial ischaemia | Non-systematic Assessment | Myocardial ischaemia |
|
| Abdominal pain NOS | Gastrointestinal disorders | Systematic Assessment | Abdominal pain NOS, Hyperthermia, Vomiting NOS |
| |
| Innappetence | Psychiatric disorders | Systematic Assessment | NAUSEA, VOMITING, LACK OF APPETENCE AFTER STRONG EMOTION |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment | Arthralgia Pain in extremity Muscle spasms |
| |
| General Disorders and Administration Site Conditions | General disorders | Systematic Assessment | Asthenia (weakness) Feeling abnormal Chest pain |
| |
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | Systematic Assessment | Hypercholesterolemia Hyperglycaemia Hyperkalaemia Hypertriglyceridaemia Hyperuricaemia Hypokalaemia Glycosylated haemoglobin increased |
| |
| Investigations | Investigations | Systematic Assessment | Blood creatine increased Blood uric acid increased Electrocardiogram abnormal Leukopenia Thrombocytopenia |
| |
| Nervous System Disorders | Nervous system disorders | Systematic Assessment | Dizziness |
| |
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment | Pollakiuria Polyuria |
| |
| Reproductive System and Breast Disorders | Reproductive system and breast disorders | Systematic Assessment | Erectile dysfunction |
| |
| Immune System Disorders | Immune system disorders | Systematic Assessment | Hypersensitivity |
| |
| Vascular Disorders | Vascular disorders | Systematic Assessment | Hypertension Hypotension |
| |
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment | Nausea Vomiting NOS |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eurofarma Laboratórios S.A | Eurofarma Laboratórios S.A | 50 11 5090-8415 | fernanda.martinez@eurofarma.com.br |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002752 | Chlorthalidone |
| D000584 | Amiloride |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
|
| V2 (30 ± 3 days after V0) |
|
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| V3 (60 ± 3 days after V0) |
|
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| V4 (90 ± 3 days after V0) |
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