INTERVENCION Trial

NCT ID: NCT02373163

Last Updated: 2025-07-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2016-06-01

Brief Summary

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This trial is designed to:

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.

Detailed Description

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Conditions

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Blood Pressure, High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diuretic

Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Telmisartan

Intervention Type DRUG

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

Intervention Type DRUG

Amlodipine

Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM

Intervention Type DRUG

Telmisartan

Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

Intervention Type DRUG

Other Intervention Names

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HCTZ

Eligibility Criteria

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Inclusion Criteria

1. Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level
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

1. Diabetes mellitus.
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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prevencion

OTHER

Sponsor Role lead

Responsible Party

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Josefina Medina-Lezama, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Investigacion PREVENCION

Arequipa, AQP, Peru

Site Status

Countries

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Peru

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.

Reference Type BACKGROUND
PMID: 20409853 (View on PubMed)

Other Identifiers

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INTERVENCION Trial

Identifier Type: -

Identifier Source: org_study_id

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