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Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02177461
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Enalapril Drug: Clonidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2000
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telmisartan Drug: Telmisartan
Active Comparator: Enalapril Drug: Enalapril
Experimental: Telmisartan + clonidine TTS1 Drug: Telmisartan
Drug: Clonidine
Active Comparator: Enalapril + clonidine TTS1 Drug: Enalapril
Drug: Clonidine

Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline and week 8 ]

Secondary Outcome Measures :
  1. Comparison of SBP ABPM tracing profile [ Time Frame: Week 8 and 24 ]
  2. Changes from baseline in trough cuff (sphygmomanometer) SBP [ Time Frame: Baseline, week 8 and 24 ]
  3. Smoothness index in comparison with baseline [ Time Frame: Baseline, week 8 and 24 ]
  4. Number of responders [ Time Frame: Week 8 and 24 ]
  5. Number of controlled responders [ Time Frame: Week 8 and 24 ]
  6. Incidence of adverse events [ Time Frame: 24 weeks ]
  7. Number of patients who withdraw due to adverse events [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02177461    
Other Study ID Numbers: 502.317
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors