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

• ClinicalTrials.gov Identifier: NCT02200653
• Recruitment Status: Completed
• First Posted: July 25, 2014
• Last Update Posted: July 25, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: July 24, 2014
• First Posted Date: July 25, 2014
• Last Update Posted Date: July 25, 2014
• Study Start Date: May 2000
• Actual Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2014)

Change from baseline in mean diastolic blood pressure [ Time Frame: Up to 8 weeks after start of treatment ]

Measured during the last 6 hours of the 24-hour dosing interval using ABPM

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 24, 2014)

• Change from baseline in mean systolic blood pressure [ Time Frame: Up to 8 weeks after start of treatment ]
  Measured during the last 6 hours of the 24-hour dosing interval using ABPM
• Changes from baseline in diastolic and systolic blood pressure [ Time Frame: Up to 8 weeks after start of treatment ]
  Measured during other times of the 24-hour ABPM profile (e.g. 24-hour mean, morning mean, daytime mean and nighttime mean)
• Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure [ Time Frame: Up to 8 weeks after start of treatment ]
  Triplicate measurement in two minute intervals after 5 minutes of rest, in seated position using sphygmomanometer
• Assessment of responder rates on ABPM [ Time Frame: Baseline, 8 weeks after start of treatment ]
• Assessment of responder rates on trough cuff blood pressure [ Time Frame: Baseline up to 8 weeks after start of treatment ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
• 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)
• Brief 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: High dose of MICARDIS®, once daily
  Other Name: Telmisartan
• Drug: Low dose of MICARDIS®, once daily
  Other Name: Telmisartan
• Drug: Low dose of COZAAR® / LORZAAR®, once daily
  Other Name: Losartan
• Drug: High dose of COZAAR® / LORZAAR®, once daily
  Other Name: Losartan
• Drug: Placebo

Study Arms

• Experimental: Low dose of MICARDIS®
  Interventions:

  • Drug: Low dose of MICARDIS®, once daily
  • Drug: Placebo
• Experimental: High dose of MICARDIS®
  Interventions:

  • Drug: High dose of MICARDIS®, once daily
  • Drug: Placebo
• Active Comparator: Low dose of COZAAR® / LORZAAR®
  Interventions:

  • Drug: Low dose of COZAAR® / LORZAAR®, once daily
  • Drug: Placebo
• Active Comparator: High dose of COZAAR® / LORZAAR®
  Interventions:

  • Drug: High dose of COZAAR® / LORZAAR®, once daily
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2014): 387
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02200653
• Other Study ID Numbers: 502.344
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: July 2014