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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00607633
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008
  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: Observational Model: Cohort
Time Perspective: 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:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Andrea Pahor, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00607633     History of Changes
Other Study ID Numbers: NIS-CGE-ATA-2007/2
Study First Received: January 23, 2008
Last Updated: February 5, 2008
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:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 22, 2014