AzTrials
AzTrials

Essential HypertensionCandLENCT00607633

Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH

An observational study of Essential Hypertension and Left Ventricular Hypertrophy, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical… Read more about this study

Who is it for?
Any age
How many people
686 participants
Where
No sites listed yet
Study dates
Jan 2007to Oct 2007
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Ambulant patient

Who may be able to join

  • essential hypertension
  • left ventricular hypertrophy
  • under candesartan treatment

Who cannot join

None listed.

About this study

Official title: Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy

The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..

Keywords
essential hypertension, ARB, left ventricular hypertrophy, candesartan
Medical subject headings
Essential Hypertension, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00607633
Study groupRoleWhat they receive
1Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index.

    Measured: app. 3 monthly

Secondary outcomes (2)
  1. to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT

    Measured: app. 3 monthly

  2. to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions.

    Measured: app. 3 monthly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2008 (estimated)
  2. Study startJan 2007
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
686 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607633
Sponsor's protocol ID
NIS-CGE-ATA-2007/2
Acronym
CandLE
Status last verified
Jan 2008
First submitted
23 Jan 2008
Last updated
6 Feb 2008
Results posted
No
Data monitoring committee
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in