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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT00607633
- Acronym / sponsor ID
- CandLE / NIS-CGE-ATA-2007/2
- Keywords
- essential hypertension, ARB, left ventricular hypertrophy, candesartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ambulant patient
Key inclusion criteria (3 listed)
- essential hypertension
- left ventricular hypertrophy
- under candesartan treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: app. 3 monthly
2 secondary outcomes
to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT
Time frame: 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.
Time frame: app. 3 monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Sonntag, MD principal investigator
Cardiologist, Henstedt-Ulzburg
Andrea Pahor, MD study chair
MED Dep., AstraZeneca Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension and Left Ventricular Hypertrophy, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: app. 3 monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2008.