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

February 8, 2008
June 17, 2014
January 2008
October 2009   (final data collection date for primary outcome measure)
  • 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.
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 ] [ 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

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
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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