Blood Pressure, HighPhase 4INTERVENCIONNCT02373163
INTERVENCION Trial
A Phase 4 study testing Hydrochlorothiazide, Amlodipine and Telmisartan in people with Blood Pressure, High, run by Prevencion at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Blood Pressure, High
- What is being tested?
- Hydrochlorothiazide, Amlodipine and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePeru
- Study dates
- 1 Sep 2014to 1 Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
This trial is designed to:
- 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.
- To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
- 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
- Being tested
- Hydrochlorothiazide, Amlodipine, Telmisartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
Also called HCTZ
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
AmlodipineDrug
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
TelmisartanDrug
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
| Study group | Role | What they receive |
|---|---|---|
| Diuretic | Active comparator | Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Receives: Drug: Hydrochlorothiazide |
| Calcium-channel blocker | Active comparator | Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Receives: Drug: Amlodipine |
| Angiotensin Receptor Blocker | Active comparator | Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
Measured: 4 weeks
Secondary outcomes (5)
Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks
Measured: 4 weeks
Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks
Measured: 4 weeks
Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks
Measured: 4 weeks
Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks
Measured: 4 weeks
Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start1 Sep 2014
- Primary completion1 Mar 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure, HighStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prevencion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefina Medina-Lezama, MD, Prevencion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373163
- Sponsor's protocol ID
- INTERVENCION Trial
- Acronym
- INTERVENCION
- Status last verified
- Jul 2025
- First submitted
- 10 Feb 2015
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20409853
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
- ClinicalTrials.gov ID
- NCT02373163
- Acronym / sponsor ID
- INTERVENCION / INTERVENCION Trial
- Conditions
- Blood Pressure, High
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- PrevencionUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to:
- 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.
- To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diuretic | Active comparator | Drug: HydrochlorothiazideTherapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM |
| Calcium-channel blocker | Active comparator | Drug: AmlodipineTherapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM |
| Angiotensin Receptor Blocker | Active comparator | Drug: TelmisartanTherapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrochlorothiazideAlso: HCTZArm: 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 | Drug | Diuretic |
| AmlodipineTherapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM | Drug | Calcium-channel blocker |
| TelmisartanTherapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM | Drug | Angiotensin Receptor Blocker |
Primary outcome
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
5 secondary outcomes
Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks
Time frame: 4 weeks
Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks
Time frame: 4 weeks
Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20409853Medina-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrochlorothiazide, Amlodipine and Telmisartan in people with Blood Pressure, High, run by Prevencion at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.