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OpenTrials
Completed

NCT Number: NCT00618774

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.16.004 Boehringer Ingelheim Investigational Site, Chofu, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with essential hypertension
  • 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"

Treatment and study plan

telmisartan40/amlodipine5

Drug

telmisartan80/amlodipine5

Drug

Primary outcomes

  1. Percentage of Participants Who Experienced Adverse Events

    Time frame: 52 weeks

    An adverse event is defined as any untoward medical occurrence

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 20, 2008
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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