Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

• ClinicalTrials.gov Identifier: NCT02177461
• Recruitment Status: Completed
• First Posted: June 27, 2014
• Last Update Posted: July 8, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02177461 History of Changes
• Other Study ID Numbers: 502.317
• First Posted: June 27, 2014
• Last Update Posted: July 8, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Telmisartan; Clonidine; Enalapril; Enalaprilat; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Enzyme Inhibitors