Add-on to Micamlo BP Trial

October 6, 2016 updated by: Boehringer Ingelheim

An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Amlodipine 5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Amlodipine 5 mg

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Atsubetsu-ku,Sapporo,Hokkaido, Japan
        • 1348.1.015 Boehringer Ingelheim Investigational Site
      • Bunkyo-ku, Tokyo, Japan
        • 1348.1.006 Boehringer Ingelheim Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • 1348.1.002 Boehringer Ingelheim Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • 1348.1.005 Boehringer Ingelheim Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • 1348.1.031 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1348.1.030 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1348.1.033 Boehringer Ingelheim Investigational Site
      • Chuo-ku,Sapporo,Hokkaido, Japan
        • 1348.1.016 Boehringer Ingelheim Investigational Site
      • Chuo-ku,Tokyo, Japan
        • 1348.1.021 Boehringer Ingelheim Investigational Site
      • Itabashi-ku, Tokyo, Japan
        • 1348.1.024 Boehringer Ingelheim Investigational Site
      • Itoshima, Fukuoka, Japan
        • 1348.1.028 Boehringer Ingelheim Investigational Site
      • Katsushika-ku, Tokyo, Japan
        • 1348.1.027 Boehringer Ingelheim Investigational Site
      • Kishiwada, Osaka, Japan
        • 1348.1.001 Boehringer Ingelheim Investigational Site
      • Kita-ku, Osaka, Japan
        • 1348.1.009 Boehringer Ingelheim Investigational Site
      • Kita-ku, Osaka, Japan
        • 1348.1.029 Boehringer Ingelheim Investigational Site
      • Kiyose,Tokyo, Japan
        • 1348.1.014 Boehringer Ingelheim Investigational Site
      • Koto-ku, Tokyo, Japan
        • 1348.1.003 Boehringer Ingelheim Investigational Site
      • Mihama-ku, Chiba, Chiba, Japan
        • 1348.1.022 Boehringer Ingelheim Investigational Site
      • Miyagino-ku, Sendai, Miyagi, Japan
        • 1348.1.004 Boehringer Ingelheim Investigational Site
      • Moriya, Ibaraki, Japan
        • 1348.1.017 Boehringer Ingelheim Investigational Site
      • Naka-ku,Yokohama,Kanagawa, Japan
        • 1348.1.013 Boehringer Ingelheim Investigational Site
      • Nishi-ku, Fukuoka, Fukuoka, Japan
        • 1348.1.018 Boehringer Ingelheim Investigational Site
      • Okinawa, Okinawa, Japan
        • 1348.1.007 Boehringer Ingelheim Investigational Site
      • Sakaide, Kagawa, Japan
        • 1348.1.020 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1348.1.025 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1348.1.026 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1348.1.008 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1348.1.032 Boehringer Ingelheim Investigational Site
      • Takamatsu, Kagawa, Japan
        • 1348.1.019 Boehringer Ingelheim Investigational Site
      • Toshima-ku, Tokyo, Japan
        • 1348.1.023 Boehringer Ingelheim Investigational Site

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

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
  • Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
  • Age 20 years or older

Exclusion criteria:

  • Patients with known or suspected secondary hypertension
  • Patients with clinically relevant cardiac arrhythmia
  • Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
  • Patients with recent cardiovascular events
  • Patients with recent stroke events
  • Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
  • Patients with hepatic and/or renal dysfunction
  • Pre-menopausal women who are nursing or pregnant

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telmisartan+amlodipine+HCTZ
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Drug: Telmisartan + amlodipine
FDC tablet
Drug: hydrochlorothiazide
tablet
ACTIVE_COMPARATOR: Telmisartan+amlodipine
telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Drug: Telmisartan + amlodipine
FDC tablet
Drug: Placebo
placebo matching hydrochlorothiazide tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Time Frame: baseline and week 8
Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Time Frame: baseline and week 8
Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
baseline and week 8
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period
Time Frame: baseline and week 8
Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.
baseline and week 8

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

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

October 29, 2013

First Posted (ESTIMATE)

November 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1348.1

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.

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