Clinical trial NCT00618774: An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Official title: An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 259
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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"

Primary outcomes:
measure: Percentage of Participants Who Experienced Adverse Events
timeFrame: 52 weeks
measure: Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
timeFrame: First administration of study treatment to 24 hours post last dosing of study treatment.
Secondary outcomes:
measure: Change From Baseline in Seated Diastolic Blood Pressure at Week 8
timeFrame: Baseline and week 8
measure: Change From Baseline in Seated Systolic Blood Pressure at Week 8
timeFrame: Baseline and week 8
measure: Seated DBP Control Rate at Trough After 8 Weeks
timeFrame: week 8
measure: Seated SBP Control Rate at Trough After 8 Weeks
timeFrame: Week 8
measure: Change From Baseline in Seated Diastolic Blood Pressure
timeFrame: Baseline and week 20 / week 48
measure: Change From Baseline in Seated Systolic Blood Pressure
timeFrame: Baseline and week 20 / week 48
measure: Seated DBP Control Rate at Trough After 6 and 12 Months
timeFrame: 6 months and 12 months
measure: Seated SBP Control Rate at Trough After 6 and 12 Months
timeFrame: 6 months and 12 months
measure: Seated DBP Response Rate at Trough
timeFrame: 6 months and 12 months
measure: Seated SBP Response Rate at Trough
timeFrame: 6 months and 12 months
measure: Seated Blood Pressure Normalisation at Trough
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Chofu, Tokyo
country: Japan
facility: 1235.16.004 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Hiroshima, Hiroshima
country: Japan
facility: 1235.16.006 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1235.16.005 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1235.16.007 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1235.16.003 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1235.16.001 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1235.16.002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: