NCT00144222

Brief Summary

The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

September 2, 2005

Last Update Submit

November 4, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in mean seated trough DBP after eight weeks of the double-blind treatment period

    after 8 weeks

Secondary Outcomes (8)

  • Change in seated trough SBP

    after 8 weeks

  • Seated DBP control rate (seated trough DBP < 90 mmHg)

    after 8 weeks

  • Seated DBP response rate V2 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg)

    after 8 weeks

  • Seated DBP response rate V3 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg)

    after 8 weeks

  • Seated SBP response rate V2 (seated trough SBP < 140 mmHg and/or reduction from pseudo-baseline in seated trough SBP ≥ 10 mmHg)

    after 8 weeks

  • +3 more secondary outcomes

Interventions

Telmisartan 40 mg/HCTZ 12.5 mgDRUG
Telmisartan 40 mgDRUG

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Essential hypertensive patients who meet all the criteria as follows:
  • Mean seated DBP must be \>= 95 and \<= 114 mmHg at Visit 2
  • Mean seated SBP must be \>= 140 and \<= 200 mmHg at Visit 2
  • Mean seated DBP must be \>= 90 and \<= 114 mmHg at Visit 3
  • Mean seated SBP must be \<= 200 mmHg at Visit 3

You may not qualify if:

  • Patients taking 4 or more anti-hypertensive medications at Visit 1
  • Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, 060-0003, Japan

Location

Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, 163-6003, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Nippon Boehringer Ingelheim Co., 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

September 2, 2005

First Posted

September 5, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

JP(2)