Candesartan Effect in Second Stage Arterial Hypertension - Full Text View

Sponsored by:	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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide CV 11974 Candesartan cilexetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

changes in mean sitting DBP [ Time Frame: 4 weeks from therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean sitting SBP from baseline [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator Candesartan cilexetil 16mg monotherapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 16 mg oral
2: Experimental Candesartan cilexetil 16mg/HCT combination therapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 16 mg oral Drug: Hydrochlorothiazide Hydrochlorothiazide 12.5 mg
3: Active Comparator candesartan cilexetil 32mg monotherapy	Drug: Candesartan Cilexetil Candesartan Cilexetil 32 mg oral
4: Experimental Candesartan Cilexetil 32 mg/HCT combination therapy	Drug: Hydrochlorothiazide Hydrochlorothiazide 12.5 mg Drug: Candesartan Cilexetil Candesartan Cilexetil 32 mg oral

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

Study ID Numbers:	D2452L00016
Study First Received:	January 24, 2008
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00621153 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Candesartan Cilexetil
hydrochlorothiazide
severe hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Sodium Chloride Symporter Inhibitors
Diuretics
Candesartan
Vascular Diseases

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Hypertension

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 May 06, 2009