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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618774
• Other study ID #: 1235.16
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2008
• Last updated: June 17, 2014
• Start date: January 2008

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• telmisartan40/amlodipine5

• telmisartan80/amlodipine5

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced Adverse Events	An adverse event is defined as any untoward medical occurrence	52 weeks	No
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	Seated DBP Control Rate at Trough After 8 Weeks	Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment	week 8	No
Secondary	Seated SBP Control Rate at Trough After 8 Weeks	Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment	Week 8	No
Secondary	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	No
Secondary	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	No
Secondary	Seated DBP Control Rate at Trough After 6 and 12 Months	Percentage of patients whose DBP <90 mmHg.	6 months and 12 months	No
Secondary	Seated SBP Control Rate at Trough After 6 and 12 Months	Percentage of patients whose SBP <140 mmHg	6 months and 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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