NCT00146341

Brief Summary

To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is superior to telmisartan 80 mg alone in patients, who fail to respond adequately to telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight weeks of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

9 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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

September 5, 2005

Last Update Submit

December 27, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is change from baseline in seated DBP at trough (24 hours post-dosing) after eight weeks of randomized treatment or at last trough observation during the double-blind phase (i.e. last trough observation carried forward).

Secondary Outcomes (1)

  • Change from baseline in seated SBP, standing DBP and SBP at trough after eight weeks of randomized treatment or at last trough observation during the double-blind phase. The percentage of patients responding to the treatment. Safety.

Interventions

Telmisartan/HCTZDRUG
TelmisartanDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who fail to respond adequately to telmisartan monotherapy (mean seated DBP \>= 90 mmHg)
  • Participants between 18 and 80 years of age
  • Ability to provide written informed consent

You may not qualify if:

  • Patients taking more than three anti-hypertensive medications at the screening visit.
  • Pre-menopausal women (last menstruation 1 year prior to start of screening):
  • Who are not surgically sterile (hysterectomy, tubal ligation)
  • Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study (acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives)
  • Any woman:
  • Who has a positive urine pregnancy test at screening (Visit 1)
  • Who is nursing
  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
  • SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal
  • Serum creatinine \> 3.0 mg/dL (or 265 mol/L) or creatinine clearance \< 0.6 ml/sec
  • Clinically relevant hypokalaemia or hyperkalaemia
  • Uncorrected volume depletion
  • Uncorrected sodium depletion
  • Primary aldosteronism
  • Hereditary fructose intolerance
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Beijing Tiantan Hospital

Beijing, 100050, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

No. 1 Hospital Affiliated Nanjing

Nanjing, 210006, China

Location

Ruijin Hospital, School of Medicine

Shanghai, 200025, China

Location

Shanghai Changhai Hospital

Shanghai, 200433, China

Location

254 PLA Hospital

Tianjin, 300150, China

Location

Second Hospital Affiliated to Tianjin Med University

Tianjin, 300211, China

Location

No. 1 Hosp Affiliated to Med College

Zhejiang Province, 310003, China

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim Shanghai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

December 28, 2017

Record last verified: 2017-12

Locations

CN(9)