Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01830530
Other study ID # 09F102
Secondary ID
Status Completed
Phase Phase 4
First received February 18, 2013
Last updated April 9, 2013
Start date May 2012
Est. completion date October 2012

Study information

Verified date February 2013
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority Peru: Instituto Nacional de SaludPeru: General Directorate of Pharmaceuticals, Devices, and Drugs
Study type Interventional

Clinical Trial Summary

This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.


Description:

This is a parallel group, prospective, double-blind, placebo controlled randomized trial, comparing the effects of combination of two antihypertensive agents (telmisartan/nifedipine)with placebo in hypertensive subjects exposed to high altitude. The principal objectives are:

1. to assess the response of BP to high altitude exposure in hypertensive subjects residing at sea level

2. To assess the efficacy and safety of combination of telmisartan 80 mg with nifedipine GITS 30 mg in preventing a possible excessive BP increase in hypertensive subjects exposed to high altitude.

The following data will be collected during the study at the different steps:

- Clinical history

- Symptoms and adverse events questionnaire

- Conventional BP and heart rate (HR) measurement - seated measurements with a validated oscillometric device will be performed after at least 5 minutes rest on non-dominant arm; two measurements will be performed 1-2 minutes apart and their average will be used in the analyses

- Vital signs:

respiratory rate - will be measured manually over 60 seconds body height and weight, waist circumference blood oxygen saturation (SpO2)

- Lake Louise Score

- 24 h ambulatory blood pressure monitoring (ABPM; AND TM2430, AND, Japan)

- Echocardiography

- Arterial properties assessment

- Six minute walking test (6MWT)

- Cardiopulmonary Exercise Test (CPET) in a subgroup of subjects

- Polysomnography with a portable device

- Pulmonary function tests (only at sea level baseline visit)

- Fluid balance chart

- Blood and urine analyses: Visit 1: electrolytes, creatinine, estimated glomerular filtration rate (eGFR), glycemia, renin, angiotensin, aldosterone, plasma catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 randomly selected subjects), samples for genetic studies. Visit 2: electrolytes, creatinine, eGFR. Visit 3: complete blood count, electrolytes, creatinine, eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma catecholamines, classic urinalysis, microalbuminuria, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 subjects selected at Visit 1). Visit 4: electrolytes, creatinine, eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 subjects selected at Visit 1)


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Permanent residence at low (<500 m) altitude

- Conventional systolic BP (average of two measurements) 140-159 mmHg or conventional diastolic BP 90-99 mmHg in subjects untreated or after 4 weeks of washout

- Mean daytime systolic BP =135 and <150 mmHg and/or mean daytime diastolic BP =85 and <95 mmHg in subjects untreated or after 4 weeks of washout

- Written informed consent to participate in the study

Exclusion Criteria:

- Conventional systolic BP (average of two measurements) =150 mmHg and conventional diastolic BP =95 mmHg in treated subjects

- Regular use of two or more antihypertensive drugs (with the exception of subjects on two antihypertensive drugs in low doses)

- Treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)

- Contraindications (including a history of adverse reactions) to angiotensin receptor blockers or calcium antagonists

- History of serious mountain sickness

- Subjects who over 3 months preceding inclusion in the study spent considerable (> 1 week) amount of time at altitudes above 2500 m.

- Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)

- Suspected or confirmed secondary hypertension

- Diabetes mellitus

- Serious respiratory disorders

- Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders)

- BMI =35 kg/m2

- Upper arm circumference >32 cm

- known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of CPAP) or excessive daytime sleepiness (Epworth Sleepiness Scale > 10)

- Pregnancy

- Premenopausal women not using effective contraceptive methods

- Elevated probability of noncompliance with the study procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Telmisartan
Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
Nifedipine
Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
placebo
two tablets daily in the morning

Locations

Country Name City State
Peru Universidad Peruana Cayetano Heredia Lima

Sponsors (2)

Lead Sponsor Collaborator
Istituto Auxologico Italiano Bayer

Country where clinical trial is conducted

Peru, 

Outcome

Type Measure Description Time frame Safety issue
Other Differences in other variables assessed in the study at high altitude between treatment groups Differences between treatment groups in polysomnographic data, arterial stiffness, blood tests, echocardiography data assessed at high altitude high altitude visit ( Visit 4) No
Other blood pressure response at sea level Changes in polysomnographic data, arterial stiffness, blood tests, echocardiography data between sea level condition and high altitude Sea level visit (3) and high altitude visit (4) No
Primary Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude Difference in 24 h ambulatory systolic BP at high altitude (Visit 4) between combination therapy group and placebo group After 6 weeks of study treatment, during high altitude visit No
Secondary Effect of study treatment on ambulatory blood pressure at high altitude (other variables) Differences in other ambulatory blood pressure (BP) variables (including 24 h diastolic BP, daytime and night-time BP, nocturnal fall of BP) at high altitude (V4) between combination therapy and placebo groups After 6 weeks of study treatment, during high altitude visit No
Secondary Lake Louise Score Differences in Lake Louise Score (score of acute mountain sickness severity) between groups After 6 weeks of study treatment, during high altitude visit Yes
Secondary Effect of high altitude on ambulatory blood pressure Change in ambulatory blood pressure between sea level condition and high altitude in both treatment groups After 6 weeks of study treatment, during high altitude visit No
Secondary Effect of high altitude on conventional blood pressure Change in conventional blood pressure between sea level condition and high altitude in both groups After 6 weeks of study treatment, during high altitude visit No
Secondary Effect of study treatment on conventional blood pressure at high altitude. Difference in conventional systolic and diastolic blood pressure at high altitude (Visit 4) between combination therapy group and placebo group After 6 weeks of study treatment, during high altitude visit No
Secondary Rate of adverse events Differences in rate of adverse events between groups. After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end). Yes
Secondary Effect of study treatment on ambulatory heart rate at high altitude Differences in ambulatory heart rate (HR) variables (including 24 h, daytime and night-time HR, and nocturnal fall of HR) at high altitude (V4) between combination therapy and placebo groups After 6 weeks of study treatment, during high altitude visit No
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A