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.
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
- Conditions the study is for
- Essential Hypertension, Left Ventricular Hypertrophy
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Patient 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.
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)
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
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.
- First posted6 Feb 2008 (estimated)
- Study startJan 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- F. Sonntag, MD, Principal investigator, Cardiologist, Henstedt-UlzburgAndrea Pahor, MD, Study chair, MED Dep., AstraZeneca Germany
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