INTERVENCION Trial

NCT02373163 | Completed Phase 4 Results

• 1 other identifier: INTERVENCION Trial
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to:

1. 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. 2.To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
3. 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.

Conditions

Blood Pressure, High

Outcome Measures

Primary Outcomes (1)

• Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks

  4 weeks

Secondary Outcomes (5)

• Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks

  4 weeks

• Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks

  4 weeks

• Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks

  4 weeks

• Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks

  4 weeks

• Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks

  4 weeks

Study Arms (3)

Diuretic

ACTIVE COMPARATOR

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

Drug: Hydrochlorothiazide

Calcium-channel blocker

ACTIVE COMPARATOR

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

Drug: Amlodipine

Angiotensin Receptor Blocker

ACTIVE COMPARATOR

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

Drug: Telmisartan

Interventions

Hydrochlorothiazide 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

Also known as: HCTZ

Diuretic

Amlodipine DRUG

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

Calcium-channel blocker

Telmisartan DRUG

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

Angiotensin Receptor Blocker

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level
• Leaving in the enrollment cities for at least 2 years
• Untreated hypertension for at least 2 weeks
• Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy.

You may not qualify if:

• Diabetes mellitus.
• Chronic kidney disease (estimated glomerular filtration rate \<60 ml / minute / 1.73 m2 of body surface area.
• Smoking.
• Lung disease, liver disease or active cancer
• Any factor that, in the opinion of the investigator, decreases short-term survival
• Psychiatric illness
• Inability to provide informed consent
• Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia)
• History of cerebrovascular disease
• History of orthostatic hypotension.
• History of syncope.
• History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.

Sponsors & Collaborators

• Prevencion: lead

Study Sites (1)

Centro de Investigacion PREVENCION

Arequipa, AQP, Peru

Location

Related Publications (1)

• 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.

  PMID: 20409853 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Amlodipine; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzimidazoles

Results Point of Contact

• Title: Josefina Medina-Lezama
• Organization: PREVENCION

jmedinal2911@gmail.com

+5154251269

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 26, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)