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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00618774
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Primary Completion: 2009-10
• Results First Submitted: 2009-12-28
• Results First Submitted QC: 2010-02-18
• Results First Posted: 2010-03-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Adverse Events	52 weeks	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Seated Diastolic Blood Pressure at Week 8	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	Baseline and week 8	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Seated DBP Control Rate at Trough After 8 Weeks	week 8	Percentage of patients whose DBP \<90 mmHg after 8 weeks of treatment
Seated SBP Control Rate at Trough After 8 Weeks	Week 8	Percentage of patients whose SBP \<140 mmHg after 8 weeks of treatment
Change From Baseline in Seated Diastolic Blood Pressure	Baseline and week 20 / week 48	Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Change From Baseline in Seated Systolic Blood Pressure	Baseline and week 20 / week 48	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Seated DBP Control Rate at Trough After 6 and 12 Months	6 months and 12 months	Percentage of patients whose DBP \<90 mmHg.
Seated SBP Control Rate at Trough After 6 and 12 Months	6 months and 12 months	Percentage of patients whose SBP \<140 mmHg
Seated DBP Response Rate at Trough	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
Seated SBP Response Rate at Trough	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
Seated Blood Pressure Normalisation at Trough	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

Trial Locations

Locations (7)

1235.16.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjyuku-ku,Tokyo, Japan

1235.16.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishi-ku, Hiroshima, Hiroshima, Japan

1235.16.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1235.16.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1235.16.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Chofu, Tokyo, Japan

1235.16.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1235.16.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan