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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00618774
First received: February 8, 2008
Last updated: June 17, 2014
Last verified: April 2014
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of patients whose SBP <140 mmHg

  • Seated DBP Response Rate at Trough [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.005 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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00618774     History of Changes
Other Study ID Numbers: 1235.16
Study First Received: February 8, 2008
Results First Received: December 28, 2009
Last Updated: June 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 20, 2014