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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: telmisartan40/amlodipine5; Drug: telmisartan80/amlodipine5

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chofu, Tokyo, Japan
    • 1235.16.004 Boehringer Ingelheim Investigational Site
  • Nishi-ku, Hiroshima, Hiroshima, Japan
    • 1235.16.006 Boehringer Ingelheim Investigational Site
  • Osaka, Osaka, Japan
    • 1235.16.005 Boehringer Ingelheim Investigational Site
  • Osaka, Osaka, Japan
    • 1235.16.007 Boehringer Ingelheim Investigational Site
  • Shinjuku-ku, Tokyo, Japan
    • 1235.16.003 Boehringer Ingelheim Investigational Site
  • Shinjyuku-ku,Tokyo, Japan
    • 1235.16.001 Boehringer Ingelheim Investigational Site
  • Suita, Osaka, Japan
    • 1235.16.002 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experienced Adverse Events	An adverse event is defined as any untoward medical occurrence	52 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	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.	First administration of study treatment to 24 hours post last dosing of study treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Seated Diastolic Blood Pressure at Week 8	mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure	Baseline and week 8
Change From Baseline in Seated Systolic Blood Pressure at Week 8	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure	Baseline and week 8
Seated DBP Control Rate at Trough After 8 Weeks	Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment	week 8
Seated SBP Control Rate at Trough After 8 Weeks	Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment	Week 8
Change From Baseline in Seated Diastolic Blood Pressure	Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure	Baseline and week 20 / week 48
Change From Baseline in Seated Systolic Blood Pressure	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure	Baseline and week 20 / week 48
Seated DBP Control Rate at Trough After 6 and 12 Months	Percentage of patients whose DBP <90 mmHg.	6 months and 12 months
Seated SBP Control Rate at Trough After 6 and 12 Months	Percentage of patients whose SBP <140 mmHg	6 months and 12 months
Seated DBP Response Rate at Trough	Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months	6 months and 12 months
Seated SBP Response Rate at Trough	Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months	6 months and 12 months
Seated Blood Pressure Normalisation at Trough	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	6 months and 12 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: February 8, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan
• Other Study ID Numbers: 1235.16