Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00608153

Purpose

The CoCa 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 subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.

Condition
Essential Hypertension

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

Resource links provided by NLM:

MedlinePlus related topics: 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 compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period. [ Time Frame: app. 3 monthly ]

Secondary Outcome Measures:

To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT [ Time Frame: app. 3 monthly ]
To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT [ Time Frame: app. 3 monthly ]
To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures [ Time Frame: app. 3 monthly ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1773
Study Start Date:	January 2007
Study Completion Date:	September 2007

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

Eligibility

Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

primary care ambulant patient

Criteria

Inclusion Criteria:

essential hypertension
under candesartan treatment

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608153

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	R. E. Schmieder, MD	University hospital Erlangen-Nurnberg
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-2007/1
Study First Received:	January 23, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00608153 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

essential hypertension
ARB
compliance
candesartan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on November 30, 2009