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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00618774
First received: February 8, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

February 8, 2008
May 18, 2012
January 2008
October 2009   (final data collection date for primary outcome measure)
Percentage of Participants Who Experienced Adverse Events [ Time Frame: 52 weeks ]
An adverse event is defined as any untoward medical occurrence
Safety during 1 year treatment
Complete list of historical versions of study NCT00618774 on ClinicalTrials.gov Archive Site
  • 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
  • Change From Baseline in Seated Diastolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]
    mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
  • Change From Baseline in Seated Systolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]
    mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Reduction in seated systolic/diastolic blood pressure (SBP/DBP) Control rate in SBP/DBP Response rate in SBP/DBP Normalisation
Not Provided
Not Provided
 
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

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
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Hypertension
  • Drug: telmisartan40/amlodipine5
  • Drug: telmisartan80/amlodipine5
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
Not Provided
October 2009   (final data collection date for primary outcome measure)

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"
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00618774
1235.16
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP