Telmisartan Versus Amlodipine in Patients With Mild-to-Moderate Hypertension

July 7, 2014 updated by: Boehringer Ingelheim

A Prospective Randomized Open-Label, Blinded-Endpoint (PROBE) Trial Comparing MICARDIS® (Telmisartan) (80 mg QD) and Amlodipine (5 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring.

The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure (BP) of ≥ 95 mm Hg and ≤ 114 mm Hg, measured by manual cuff sphygmomanometer, on the last visit (Visit 6) of the four-week placebo run-in period (baseline BP)
  • Mean seated systolic blood pressure ≥ 140 mm Hg and ≤ 200 mm Hg, measured by manual cuff at Visit 6 (baseline BP)
  • A 24-hour mean ABPM measurement of ≥ 130/85 mm Hg evaluated at Visit 7 (baseline ABPM)
  • Age 18 or older
  • Ability to provide written informed consent

Exclusion Criteria:

  • Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening):

    • who are not surgically sterile (hysterectomy, tubal ligation)
    • who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study

  • Any women:

    • Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 7)
    • Who is nursing

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

    • SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
    • Serum creatinine > 2.3 mg/dL
  • At screening (Visit 1): clinically relevant sodium depletion, hyperkalemia, or hypokalemia
  • Known or suspected secondary hypertension
  • Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
  • Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
  • Unstable angina within the past three months
  • Stroke within the past six months
  • Myocardial infarction or cardiac surgery within the past three months
  • PTCA (percutaneous transluminal coronary angioplasty) within the past three months
  • History of angioedema
  • 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
  • Administration of digoxin or other digitalis-type drugs
  • Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
  • Known drug or alcohol dependency within the past one year period
  • Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
  • Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 AM (ante meridian)
  • Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous MICARDIS (telmisartan) studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan
4-week placebo run-in, 8-week fixed dose period
Drug: Placebo
Drug: Telmisartan
Active Comparator: Amlodipine
4-week placebo run-in, 8-week fixed dose period
Drug: Placebo
Device: Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in diastolic and systolic blood pressure during the last six hours of a 24-hour dosing interval, measured by ambulatory blood pressure monitoring
Time Frame: Baseline (day 1), day 57 of the open-label period
Baseline (day 1), day 57 of the open-label period

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in diastolic and systolic blood pressure during other times during the 24-hour ABPM profile
Time Frame: Baseline (day 1), up to day 57 of the open-label period
Baseline (day 1), up to day 57 of the open-label period
Changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff
Time Frame: Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period
Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period
Blood pressure responder rates based on ABPM
Time Frame: day 56 and 57 of the open-label period
day 56 and 57 of the open-label period
Blood pressure responder rates based on manual cuff measurements
Time Frame: days 14, 28, 56 and 57 of the open-label period
days 14, 28, 56 and 57 of the open-label period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Primary Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe