Phase 4
Completed N=166
INTERVENCION Trial
Blood Pressure, High
Source: ClinicalTrials.gov NCT02373163 ↗
Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks — -5.9; -7.5; -8.4 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks |
-5.9; -7.5; -8.4 | — |
| SECONDARY Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks |
-3.5; -4.7; -5.6 | — |
| SECONDARY Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks |
-4.6; -6.0; -6.9 | — |
| SECONDARY Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks |
-2.4; -2.8; -2.8 | — |
| SECONDARY Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks |
-11.6; -9.6; -11.2 | — |
| SECONDARY Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks |
-0.4; -0.3; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02373163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.