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An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00618774
First Posted: February 20, 2008
Last Update Posted: June 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Condition Intervention Phase
Hypertension Drug: telmisartan40/amlodipine5 Drug: telmisartan80/amlodipine5 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Participants Who Experienced Adverse Events [ Time Frame: 52 weeks ]
    An adverse event is defined as any untoward medical occurrence

  • Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG [ Time Frame: First administration of study treatment to 24 hours post last dosing of study treatment. ]
    Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.


Secondary Outcome Measures:
  • Change From Baseline in Seated Diastolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
    mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure

  • Change From Baseline in Seated Systolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
    mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

  • Seated DBP Control Rate at Trough After 8 Weeks [ Time Frame: week 8 ]
    Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment

  • Seated SBP Control Rate at Trough After 8 Weeks [ Time Frame: Week 8 ]
    Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment

  • Change From Baseline in Seated Diastolic Blood Pressure [ Time Frame: Baseline and week 20 / week 48 ]
    Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure

  • Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline and week 20 / week 48 ]
    mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

  • Seated DBP Control Rate at Trough After 6 and 12 Months [ Time Frame: 6 months and 12 months ]
    Percentage of patients whose DBP <90 mmHg.

  • Seated SBP Control Rate at Trough After 6 and 12 Months [ Time Frame: 6 months and 12 months ]
    Percentage of patients whose SBP <140 mmHg

  • Seated DBP Response Rate at Trough [ Time Frame: 6 months and 12 months ]
    Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months

  • Seated SBP Response Rate at Trough [ Time Frame: 6 months and 12 months ]
    Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months

  • Seated Blood Pressure Normalisation at Trough [ Time Frame: 6 months and 12 months ]

    Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:

    Optimal: SBP <120 mmHg and DBP <80 mmHg

    Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg

    High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg

    No: SBP >=140 mmHg or DBP >=90 mmHg



Enrollment: 259
Study Start Date: January 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with essential hypertension
  2. Outpatient

Exclusion Criteria:

  • Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
  • Patients who have met any of the exclusion criteria defined in the "non-responder trials"
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618774


Locations
Japan
1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00618774     History of Changes
Other Study ID Numbers: 1235.16
First Submitted: February 8, 2008
First Posted: February 20, 2008
Results First Submitted: December 28, 2009
Results First Posted: March 3, 2010
Last Update Posted: June 27, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Telmisartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists