NCT00224549

Brief Summary

The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4 hypertension

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

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 28, 2011

Status Verified

March 1, 2007

Enrollment Period

4.3 years

First QC Date

September 16, 2005

Last Update Submit

February 25, 2011

Conditions

Hypertension

Keywords

Resistant hypertensionCombined diuretic therapyCombined RAS blockers

Outcome Measures

Primary Outcomes (1)

  • Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device

    Mean day-time systolic blood pressure (SBP) at week 12, measured with an average blood pressure measurement (ABPM) device

    at week 12

Secondary Outcomes (11)

  • Efficacy: mean day-time diastolic blood pressure (DBP) at week 12, mean 24 hours SBP and DBP at week 12 measured with an ABPM device

    at week 12,

  • Safety and tolerability:

    during the study

  • During the study BP will be evaluated every 4 weeks by home blood pressure measurement [HBPM] in order to detect hypotension)

    every 4 weeks

  • Biological examinations:

    during the study

  • blood and urinary electrolytes with creatinemia at week 0, 4, 8, 10 and 12

    at week 0, 4, 8, 10 and 12

  • +6 more secondary outcomes

Interventions

irbesartan, amlodipine and hydrochlorothiazideDRUG

irbesartan, amlodipine and hydrochlorothiazide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary hypertension
  • Resistant hypertension defined by mean day-time SBP \> 135 mmHg and DBP \> 85 mmHg (determined with ABPM device) after a standardized 4-week regimen including irbesartan, amlodipine and HCTZ.

You may not qualify if:

  • Secondary hypertension
  • Unstable angina, history of stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months
  • History of cough with ACEi or gynecomastia with antialdosterones
  • Heart failure (New York Heart Association \[NYHA\] III-IV)
  • Contraindication to beta blockers because of bronchopathy or auriculoventricular block
  • Diabetes mellitus (type 1 or 2) with HbA1C \> 8%
  • Renal failure with creatinine clearance \< 40ml/min (COCKROFT evaluation)
  • Arm circumference \> 42 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigation Clinical Center European Georges Pompidou Hospital

Paris, Île-de-France Region, 75015, France

Location

Related Publications (2)

  • Mendes M, Dubourg J, Blanchard A, Bergerot D, Courand PY, Forni V, Frank M, Bobrie G, Menard J, Azizi M. Copeptin is increased in resistant hypertension. J Hypertens. 2016 Dec;34(12):2458-2464. doi: 10.1097/HJH.0000000000001106.

    PMID: 27755389DERIVED

  • Frank M, Peyrard S, Bobrie G, Azizi M. Method of mean value calculation as an additional source of variability in ambulatory blood pressure measurement. Am J Hypertens. 2010 Jul;23(7):725-31. doi: 10.1038/ajh.2010.47. Epub 2010 Mar 25.

    PMID: 20339354DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

IrbesartanAmlodipineHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDihydropyridinesPyridinesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Guillaume BOBRIE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 23, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 28, 2011

Record last verified: 2007-03

Locations

FR(1)