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

NCT02200653 | Completed Phase 4

• 1 other identifier: 502.344
• Study Type: interventional
• Target: 387
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean diastolic blood pressure

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

  Up to 8 weeks after start of treatment

Secondary Outcomes (5)

• Change from baseline in mean systolic blood pressure

  Up to 8 weeks after start of treatment

• Changes from baseline in diastolic and systolic blood pressure

  Up to 8 weeks after start of treatment

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

  Up to 8 weeks after start of treatment

• Assessment of responder rates on ABPM

  Baseline, 8 weeks after start of treatment

• Assessment of responder rates on trough cuff blood pressure

  Baseline up to 8 weeks after start of treatment

Study Arms (4)

Low dose of MICARDIS®

EXPERIMENTAL

Drug: Low dose of MICARDIS®, once daily; Drug: Placebo

High dose of MICARDIS®

EXPERIMENTAL

Drug: High dose of MICARDIS®, once daily; Drug: Placebo

Low dose of COZAAR® / LORZAAR®

ACTIVE COMPARATOR

Drug: Low dose of COZAAR® / LORZAAR®, once daily; Drug: Placebo

High dose of COZAAR® / LORZAAR®

ACTIVE COMPARATOR

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

Interventions

High dose of MICARDIS®, once daily DRUG

Also known as: Telmisartan

High dose of MICARDIS®

Low dose of MICARDIS®, once daily DRUG

Also known as: Telmisartan

Low dose of MICARDIS®

Low dose of COZAAR® / LORZAAR®, once daily DRUG

Also known as: Losartan

Low dose of COZAAR® / LORZAAR®

High dose of COZAAR® / LORZAAR®, once daily DRUG

Also known as: Losartan

High dose of COZAAR® / LORZAAR®

Placebo DRUG

High dose of COZAAR® / LORZAAR®; High dose of MICARDIS®; Low dose of COZAAR® / LORZAAR®; Low dose of MICARDIS®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: May 1, 2000
• Primary Completion: February 1, 2001
• Last Updated: July 25, 2014

Record last verified: 2014-07