An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

June 17, 2014 updated by: Boehringer Ingelheim

8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

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

  • China
      • Beijing, China
        • 1235.29.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1235.29.86004 Boehringer Ingelheim Investigational Site
      • Changchun, China
        • 1235.29.86006 Boehringer Ingelheim Investigational Site
      • Changsha, China
        • 1235.29.86013 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1235.29.86014 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1235.29.86012 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1235.29.86002 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1235.29.86009 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1235.29.86010 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1235.29.86011 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 1235.29.86007 Boehringer Ingelheim Investigational Site
      • Tianjin, China
        • 1235.29.86008 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Johor, Malaysia
        • 1235.29.60017 Boehringer Ingelheim Investigational Site
      • Kuala Lumpur, Malaysia
        • 1235.29.60016 Boehringer Ingelheim Investigational Site
  • Philippines
      • Metro Manila, Philippines
        • 1235.29.63018 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1235.29.63019 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. diagnosis of essential hypertension
  2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
  3. provision of written informed consent

Exclusion criteria:

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan80mg+Amlodipine5mg
combination therapy
Drug: Telmisartan80mg+Amlodipine5mg
combination therapy
Active Comparator: amlodipine 5 mg
Monotherapy
Drug: amlodipine 5mg
monotherapy
Drug: Telmisartan80mg+Amlodipine 5mg
combination therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in DBP After 8 Weeks of Treatment
Time Frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Baseline and 8 weeks
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Time Frame: Baseline and 8 weeks
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in SBP After 8 Weeks of Treatment
Time Frame: Baseline and 8 weeks
Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Baseline and 8 weeks
DBP and SBP Control and Response After 8 Weeks of Treatment
Time Frame: Baseline and 8 weeks
DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
Baseline and 8 weeks
Number of Patients in Blood Pressure Categories Over Time
Time Frame: 8 weeks
BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
8 weeks
Change From Baseline in DBP After 4 Weeks of Treatment
Time Frame: Baseline and 4 weeks
Seated trough DBP after 4 weeks.
Baseline and 4 weeks
Change From Baseline in SBP After 4 Weeks of Treatment
Time Frame: Baseline and 4 weeks
Seated trough SBP after 4 weeks.
Baseline and 4 weeks
DBP and SBP Control and Response After 4 Weeks of Treatment
Time Frame: Baseline and 4 weeks
DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
Baseline and 4 weeks
Number of Patients in Blood Pressure Categories at 4 Weeks
Time Frame: 4 weeks
BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
4 weeks
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
Time Frame: From drug administration until end of treatment plus one day
Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
From drug administration until end of treatment plus one day

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.

General Publications

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

July 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235.29

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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