Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

NCT ID: NCT01204398

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30

Brief Summary

The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eligible hypertension patient

Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Group Type: EXPERIMENTAL

telmisartan+amlodipine fixed dose combination

Intervention Type: DRUG

after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Interventions

telmisartan+amlodipine fixed dose combination

after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged at least 18 years at the date of signing the consent form

2. For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry

3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

Exclusion Criteria

1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg

2. any clinically significant hepatic impairment

3. severe renal impairment

4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant

5. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped

6. other conditions or situations that could put potential participants at unacceptable risk due to participation in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1235.31.86001 Boehringer Ingelheim Investigational Site

Shanghai, , China

Countries

China

Other Identifiers

1235.31

Identifier Type: -

Identifier Source: org_study_id