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Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Enalapril (Drug); Clonidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.

Clinical Details

Official title: A PROBE (Prospective, Randomised, Open-Label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)

Secondary outcome:

Comparison of SBP ABPM tracing profile

Changes from baseline in trough cuff (sphygmomanometer) SBP

Smoothness index in comparison with baseline

Number of responders

Number of controlled responders

Incidence of adverse events

Number of patients who withdraw due to adverse events

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 65 years

- Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure

(DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period

- Written informed consent

Exclusion Criteria:

- Secondary hypertension

- Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)

- Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L,

clinically significant hyperkaliemia as defined by serum potassium level > 5. 5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level < 3. 0 mEq/L

- Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which

could interfere with the cardiac rhythm

- Heart rate < 50 bpm

- Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class

CHF III-IV)

- Angina pectoris or myocardial infarction

- Cardiac surgery within the past 3 months prior to start the wash-out period

- Stroke within the past 6 months prior to start the wash-out period

- Renal insufficiency defined as creatininaemia > 2mg/dl

- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post

renal transplant

- Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate

aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range

- Clinically significant metabolic and endocrine disease

- Autoimmune disease

- Previous history of angioedema

- Body mass index > 30kg/m2

- Arm circumference > 32 cm

- Any condition that may be likely to compromise the trial (alcohol or drug abuse,

disability illness, etc.)

- Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present

use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure

- Investigational drug treatment within the past 30 days before the enrolment or

concurrent participation to any other trial

- Sensitivity, significant adverse reaction or contraindications to the study drugs

(telmisartan, enalapril, clonidine TTS)

- Predictable lack of patient co-operation

Locations and Contacts

Additional Information

Starting date: April 2000
Last updated: July 7, 2014

Page last updated: August 23, 2015

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