NCT00133185

Brief Summary

The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

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

March 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

August 22, 2005

Last Update Submit

November 18, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.

    8 weeks

Secondary Outcomes (1)

  • Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated.

    8 weeks

Interventions

telmisartan 40 mg/hydrochlorothiazide 12.5 mgDRUG
losartan 50 mg/hydrochlorothiazide 12.5 mgDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate hypertension as defined by a morning mean(\>95 and \<115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be \>140 and \<200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
  • Male or female between 20 to 80 years old
  • Ability to provide written informed consent.

You may not qualify if:

  • Patients are still taking more than three anti-hypertensives at the screening visit
  • Pre-menopausal women
  • Known or suspected secondary hypertension
  • Mean sitting DBP\<95mmHg and/or mean sitting SBP \> 200mmHg at the end of placebo run-in phase
  • Hepatic and/or renal dysfunction
  • Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
  • Known NYHA functional class Chronic Heart Failure (CHF) III, IV
  • Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
  • Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
  • Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (\>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  • Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
  • Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
  • Clinically significant hyperkalemia as defined by serum potassium level \>5.5 mmol/L
  • Non-insulin dependent DM poorly controlled whicih is defined as HbA1c\>8% twice consecutively within 6 months and/or AC blood sugar\>180 mg/dl.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Machay Memorial Hospital

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanHydrochlorothiazideLosartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazoles

Study Officials

  • Boehringer Ingelheim Study Coordinator

    B.I. Taiwan Ltd.

    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

August 22, 2005

First Posted

August 23, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

TW(1)