NCT00550953

Brief Summary

The primary purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P50-P75 for phase_3 hypertension

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 2, 2010

Completed
Last Updated

January 30, 2014

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

October 26, 2007

Results QC Date

November 12, 2009

Last Update Submit

December 12, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks

    The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

    Baseline and 8 Weeks

Secondary Outcomes (7)

  • Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks

    Baseline and 8 weeks

  • Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

    8 weeks

  • Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

    8 weeks

  • Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

    8 weeks

  • Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

    8 weeks

  • +2 more secondary outcomes

Interventions

telmisartan+amlodipineDRUG
telmisartanDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertensive patients who satisfying non-responder criteria
  • Male or Female
  • Age 20 years or older
  • Outpatient

You may not qualify if:

  • Taking four or more anti-hypertensive medications
  • Secondary hypertension
  • Mean seated diastolic blood pressure (DBP) \> 114 mmHg and/or mean seated systolic blood pressure (SBP) \> 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP \< 90 mmHg at Visit 3.
  • Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
  • Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
  • History of myocardial infarction or cardiac surgery within last 6 months
  • History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
  • History of unstable angina within last 3 months
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
  • History of stroke or transient ischemic attack within last 6 months
  • History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
  • Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
  • Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
  • Hepatic and/or renal dysfunction
  • Diagnosed biliary atresia or cholestasis
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

1235.14.002 Boehringer Ingelheim Investigational Site

Chofu, Tokyo, Japan

Location

1235.14.003 Boehringer Ingelheim Investigational Site

Musashino, Tokyo, Japan

Location

1235.14.005 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, Japan

Location

1235.14.004 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1235.14.001 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combinationTelmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2007

First Posted

October 30, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Last Updated

January 30, 2014

Results First Posted

February 2, 2010

Record last verified: 2013-12

Locations

JP(5)