Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

NCT01204398 | Completed Phase 3 Results

• 1 other identifier: 1235.31
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean

  ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.

  8 weeks

Secondary Outcomes (6)

• Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing

  8 weeks

• Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment

  8 weeks

• Change From Baseline to End of Study in DBP and SBP

  8 weeks

• ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing

  0 and 8 weeks

• Treatment Emergent Adverse Events

  8 weeks

Study Arms (1)

eligible hypertension patient

EXPERIMENTAL

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

Drug: telmisartan+amlodipine fixed dose combination

Interventions

telmisartan+amlodipine fixed dose combination DRUG

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

eligible hypertension patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years at the date of signing the consent form
• 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
• hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

You may not qualify if:

• mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
• any clinically significant hepatic impairment
• severe renal impairment
• bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
• current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
• other conditions or situations that could put potential participants at unacceptable risk due to participation in this study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1235.31.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Last Updated: June 27, 2014
• Results First Posted: August 24, 2012

Record last verified: 2013-12

Locations

CN (1)