Candesartan Effect in Second Stage Arterial Hypertension - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00621153

Purpose

To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen

Condition	Intervention	Phase
Stage II Hypertension	Drug: Candesartan Cilexetil Drug: Hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults

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:

Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of the changed DBP from baseline after 4 weeks

Secondary Outcome Measures:

Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of the changed SBP from baseline after 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Percent of the patients achieving goal DBP and SBP after 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent of patients achieving goal of DBP
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Changed SBP from baseline after 8 weeks
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change of hs-CRP from basline after 8 weeks
Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
Compliance Levels at 4 Weeks and 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent of the number of returened pills to the number of prescrited pills

Enrollment:	214
Study Start Date:	February 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Candesartan cilexetil 16mg monotherapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 16 mg oral Other Name: Atacand
Experimental: 2 Candesartan cilexetil 16mg/HCT combination therapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 16 mg oral Other Name: Atacand Drug: Hydrochlorothiazide Hydrochlorothiazide 12.5 mg Other Names: HCTZ Diazide
Active Comparator: 3 candesartan cilexetil 32mg monotherapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 32 mg oral Other Name: Atacand
Experimental: 4 Candesartan Cilexetil 32 mg/HCT combination therapy	Drug: Hydrochlorothiazide Hydrochlorothiazide 12.5 mg Other Names: HCTZ Diazide Drug: Candesartan Cilexetil Candesartan Cilexetil 32 mg oral Other Name: Atacand

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion Criteria:

Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621153

Locations

Korea, Republic of
Research Site
Seoul, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Dong Hoon Choi	Severance Hospital
Study Director:	Joonwoo Bahn	AstraZeneca Korea

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00621153 History of Changes
Other Study ID Numbers:	D2452L00016
Study First Received:	January 24, 2008
Results First Received:	February 24, 2010
Last Updated:	February 24, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Candesartan Cilexetil
hydrochlorothiazide
severe hypertension

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Antihypertensive Agents
Hydrochlorothiazide
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012