Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
166 participants
INTERVENTIONAL
2014-09-01
2016-06-01
Brief Summary
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1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level.
2. To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
3. To assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diuretic
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Hydrochlorothiazide
Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Calcium-channel blocker
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Amlodipine
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Angiotensin Receptor Blocker
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Telmisartan
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Interventions
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Hydrochlorothiazide
Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Amlodipine
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Telmisartan
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Leaving in the enrollment cities for at least 2 years
3. Untreated hypertension for at least 2 weeks
4. Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy.
Exclusion Criteria
2. Chronic kidney disease (estimated glomerular filtration rate \<60 ml / minute / 1.73 m2 of body surface area.
3. Smoking.
4. Lung disease, liver disease or active cancer
5. Any factor that, in the opinion of the investigator, decreases short-term survival
6. Psychiatric illness
7. Inability to provide informed consent
8. Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia)
9. History of cerebrovascular disease
10. History of orthostatic hypotension.
11. History of syncope.
12. History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.
50 Years
80 Years
ALL
No
Sponsors
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Prevencion
OTHER
Responsible Party
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Josefina Medina-Lezama, MD
Principal Investigator
Locations
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Centro de Investigacion PREVENCION
Arequipa, AQP, Peru
Countries
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References
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Medina-Lezama J, Zea-Diaz H, Morey-Vargas OL, Bolanos-Salazar JF, Postigo-Macdowall M, Paredes-Diaz S, Corrales-Medina F, Valdivia-Ascuna Z, Cuba-Bustinza C, Villalobos-Tapia P, Munoz-Atahualpa E, Chirinos-Pacheco J, Raij L, Chirinos JA. Prevalence and patterns of hypertension in Peruvian Andean Hispanics: the PREVENCION study. J Am Soc Hypertens. 2007 May-Jun;1(3):216-25. doi: 10.1016/j.jash.2007.02.003.
Other Identifiers
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INTERVENCION Trial
Identifier Type: -
Identifier Source: org_study_id
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