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A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)

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: High dose of MICARDIS®, once daily (Drug); Low dose of MICARDIS®, once daily (Drug); Low dose of COZAAR® / LORZAAR®, once daily (Drug); High dose of COZAAR® / LORZAAR®, once daily (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure

Clinical Details

Official title: A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR / LORZAAR (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in mean diastolic blood pressure

Secondary outcome:

Change from baseline in mean systolic blood pressure

Changes from baseline in diastolic and systolic blood pressure

Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure

Assessment of responder rates on ABPM

Assessment of responder rates on trough cuff blood pressure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥

95 mmHg and ≤ 109 mmHg, measured by manual cuff sphygmomanometer, at Visit 3 (baseline cuff BP)

- A 24-mean DBP of ≥ 85 mmHg at Visit 4 as measured by ABPM

- Age 18 years or older

- Ability to stop current antihypertensive therapy without risk to the patient

(investigator's discretion)

- Patient's written informed consent in accordance with good clinical practice (GCP)

and local legislation Exclusion Criteria:

- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period)

who:

- are not surgically sterile; and/or

- are nursing

- are of child-bearing potential and are NOT practising acceptable means of birth

control, do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives

- Known or suspected secondary hypertension

- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the

placebo run-in period

- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

- Serum glutamate-pyruvate-transaminase (alanine aminotransferase) or serum

glutamate-oxaloacetate-transaminase (aspartate aminotransferase) > than 2 times the upper limit of normal range

- Serum creatinine > 2. 3 mg/dL (or > 203 µmol/l)

- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; patients

post-renal transplant or with only one kidney

- Clinically relevant sodium depletion, hypokalaemia, or hyperkalaemia

- Uncorrected volume depletion

- Primary aldosteronism

- Hereditary fructose intolerance

- Biliary obstructive disorders

- Patients who have previously experienced symptoms characteristic of angioedema during

treatment with ACE inhibitors or angiotensin II receptor antagonists

- History of drug or alcohol dependency within 6 months

- Chronic administration of any medications known to affect blood pressure, except

medications allowed by the protocol

- Any investigational therapy within one month of signing the informed consent form

- Congestive heart failure (NYHA functional class congestive heart failure (CHF) class

III-IV)

- Unstable angina within the past six months

- Stroke within the past six months

- Myocardial infarction or cardiac surgery within the past six months

- Percutaneous transluminal coronary angioplasty (PTCA) within the past six months

- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other

clinically relevant cardiac arrhythmias as determined by the investigator

- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant

stenosis of the aortic or mitral valve

- Patients with insulin-dependent diabetes mellitus whose diabetes hast not been stable

and controlled for at least the past three months as defined by an HbA1c ≥ 10%

- Night shift workers who routinely sleep during the daytime and whose work hours

include midnight to 4: 00 ante meridiem (AM)

- Known hypersensitivity to any component of the formulations

- Any clinical condition which, in the opinion of the investigator would not allow safe

completion of the protocol and safe administration of trial medication

Locations and Contacts

Additional Information

Starting date: May 2000
Last updated: July 24, 2014

Page last updated: August 23, 2015

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