Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00607633

Purpose

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..

Condition
Essential Hypertension Left Ventricular Hypertrophy

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	686
Study Start Date:	January 2007
Study Completion Date:	October 2007

Groups/Cohorts
1 Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT

Eligibility

Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Ambulant patient

Criteria

Inclusion Criteria:

essential hypertension
left ventricular hypertrophy
under candesartan treatment

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607633

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	F. Sonntag, MD	Cardiologist, Henstedt-Ulzburg
Study Chair:	Andrea Pahor, MD	MED Dep., AstraZeneca Germany

More Information

No publications provided

Responsible Party:	AstraZeneca Germany ( Andrea Pahor )
Study ID Numbers:	NIS-CGE-ATA-2007/2
Study First Received:	January 23, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00607633 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

essential hypertension
ARB
left ventricular hypertrophy
candesartan

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Candesartan cilexetil
Hypertrophy
Natriuretic Agents
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Cardiomegaly
Hypertension

ClinicalTrials.gov processed this record on November 22, 2009