Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension (CARD)
This study is currently recruiting participants.
Verified January 2012 by Eurofarma Laboratorios S.A.
Sponsor:
Eurofarma Laboratorios S.A.
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01191450
First received: August 26, 2010
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Hypertension |
Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg Drug: Higroton® Laboratório Novartis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension |
Resource links provided by NLM:
Further study details as provided by Eurofarma Laboratorios S.A.:
Primary Outcome Measures:
- Potassium level [ Time Frame: After starting the medication ] [ Designated as safety issue: Yes ]Potassium level <4.0 mEq/L after starting the medication.
Secondary Outcome Measures:
- Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment.
| Estimated Enrollment: | 280 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Higroton®
Chlorthalidone 25mg - one oral tablet a day in the morning
|
Drug: Higroton® Laboratório Novartis
Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
Other Name: Higroton® Laboratório Novartis
|
|
Experimental: Diupress®
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
|
Drug: 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
Other Name: Diupress® (Eurofarma Laboratórios Ltda.)
|
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
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191450
Contacts
| Contact: Estela B Pannuti | 55 11 4144-9680 | estela.pannuti@eurofarma.com.br |
Locations
| Brazil | |
| Centro de Estudos de Diabetes e Hipertensão | Recruiting |
| Fortaleza, Ceará, Brazil | |
| Contact: Viviana 55 85 3105-8300 cedh@cedh.med.br | |
| Principal Investigator: Adriana C Forti | |
| CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo | Recruiting |
| Vitória, Espirito Santo, Brazil | |
| Contact: Ana Carolina 55 27 21250220 pesquisa2@cedoes.com.br | |
| Principal Investigator: Daniela G Barbieri | |
| Liga de Hipertensão Arterial - Universidade Federal de Goiás | Recruiting |
| Goiânia, Goiás, Brazil | |
| Contact: Ana Paula Souza 55 62 3269-8433 anapauladesouza@hotmail.com | |
| Principal Investigator: Paulo Cesar V Jardim | |
| UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP | Recruiting |
| Botucatu, São Paulo, Brazil | |
| Contact: Mônica 55 14 3811-6574 mapaula@fmb.unesp.br | |
| Sub-Investigator: Roberto Jorge S Franco | |
| Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares | Recruiting |
| São José do Rio Preto, São Paulo, Brazil | |
| Contact: Clotilde 55 17 3203-4051 dcimc@imconline.com.br | |
| Principal Investigator: José Carlos A Ayoub | |
| Instituto de Moléstias Cardiovasculares de Tatuí | Recruiting |
| Tatuí, São Paulo, Brazil | |
| Contact: Lucas Frare 55 15 3305 1260 lucasfrare@yahoo.com.br | |
| Principal Investigator: Fábio José C Fucci | |
| Hospital Santa Marcelina | Recruiting |
| São Paulo, Brazil | |
| Contact: Isabel 55 11 2217-3766 isabelcpchsm@santamarcelina.org | |
| Principal Investigator: Paulo Guilherme O Silva | |
| Clínica Paulista de Doenças Cardiovasculares - FGM | Recruiting |
| São Paulo, Brazil | |
| Contact: Raquel 55 11 3373-7310 | |
| Principal Investigator: Fernando Augusto A Costa | |
| IMA - Instituto de Medicina Avançada | Recruiting |
| São Paulo, Brazil | |
| Contact: Daniela Fakih 55 11 38639156 daniela.fakih@imabrasil.com.br | |
| Principal Investigator: Marise L Castro | |
| Hospital São Camilo | Recruiting |
| São Paulo, Brazil | |
| Contact: Mariana Gonçalves 55 11 3677-4444 ext 5015 pesquisa.iep@saocamilo.com | |
| Principal Investigator: Humberto Freitas | |
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
| Principal Investigator: | 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 |
| Principal Investigator: | Fábio José C Fucci | Instituto de Moléstias Cardiovasculares de Tatuí |
More Information
No publications provided
| Responsible Party: | Eurofarma Laboratorios S.A. |
| ClinicalTrials.gov Identifier: | NCT01191450 History of Changes |
| Other Study ID Numbers: | EF 114 |
| Study First Received: | August 26, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by Eurofarma Laboratorios S.A.:
|
chlortalidone amiloride arterial hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amiloride Chlorthalidone Lactitol Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Antihypertensive Agents Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013