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Trial record 50 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

INTERVENCION Trial (INTERVENCION)

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ClinicalTrials.gov Identifier: NCT02373163
Recruitment Status : Unknown
Verified October 2015 by Josefina Medina-Lezama, MD, Prevencion.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Josefina Medina-Lezama, MD, Prevencion

Brief 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.

Condition or disease Intervention/treatment Phase
Blood Pressure, High Drug: Hydrochlorothiazide Drug: Amlodipine Drug: Telmisartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
Study Start Date : September 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Diuretic
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
Drug: 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
Other Name: HCTZ

Active Comparator: Calcium-channel blocker
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
Drug: Amlodipine
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM

Active Comparator: Angiotensin Receptor Blocker
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Drug: Telmisartan
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM




Primary Outcome Measures :
  1. Change is 24-hour Systolic blood pressure from baseline to 4 weeks [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of participants with controlled BP at 4 weeks [ Time Frame: 4 weeks ]
  2. Change in 24-hour Diastolic blood pressure from baseline to 4 weeks [ Time Frame: 4 weeks ]
  3. Change in 24-hour Mean arterial pressure from baseline to 4 weeks [ Time Frame: 4 weeks ]
  4. Change in 24 hour Pulse pressure from baseline to 4 weeks [ Time Frame: 4 weeks ]
  5. Change in Central (aortic) pulse pressure from baseline to 4 weeks [ Time Frame: 4 weeks ]
  6. Change in Carotid-femoral pulse wave velocity from baseline to 4 weeks [ Time Frame: 4 weeks ]
  7. Change in the magnitude of Wave reflections from baseline to 4 weeks [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373163


Contacts
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Contact: Josefina E Medina-Lezama, MD +5154251269 Josefina Medina <jmedinal2911@gmail.com>

Locations
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Peru
Centro de Investigacion PREVENCION Recruiting
Arequipa, AQP, Peru
Contact: Josefina E Medina-Lezama, MD    +5154251269    Josefina Medina <jmedinal2911@gmail.com>   
Sponsors and Collaborators
Prevencion

Publications:
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Responsible Party: Josefina Medina-Lezama, MD, Principal Investigator, Prevencion
ClinicalTrials.gov Identifier: NCT02373163     History of Changes
Other Study ID Numbers: INTERVENCION Trial
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hydrochlorothiazide
Telmisartan
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers