Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00383929
First received: October 3, 2006
Last updated: March 19, 2008
Last verified: March 2008
  Purpose

In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.


Condition Intervention Phase
Hypertension
Drug: Candesartan cilexetil
Drug: Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change (reduction) in sitting BP (24 hours after dose) [ Time Frame: Assessed from baseline (randomisation) to the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with controlled sitting BP in each treatment group [ Time Frame: Assessed at the end of the study ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events and discontinuation of study medication due to AEs from baseline (randomisation) to the end of the study [ Time Frame: Assessed from baseline (randomisation) to the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 1979
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Candesartan Cilexetil (CC) /HCT 32/12.5mg
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND
Drug: Hydrochlorothiazide
12.5 mg oral
Other Name: HCTZ
Experimental: 2
Candesartan Cilexetil (CC) /HCT 32/25mg
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND
Drug: Hydrochlorothiazide
25 mg oral
Other Name: HCTZ
Experimental: 3
Candesartan Cilexetil monotherapy
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
  • Provision of signed Informed Consent
  • Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs, which the patient and the physician are willing to withdraw at enrolment and change to candesartan monotherapy
  • Mean sitting DBP 90-114 mmHg
  • Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
  • Mean sitting DBP 90-114 mmHg on treatment with candesartan 32 mg monotherapy (after 2 weeks with candesartan 16 mg and 6 weeks with candesartan 32 mg monotherapy). The run-in period should not be shorter than 8 weeks.

Exclusion Criteria:

  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
  • Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant and verified by a negative pregnancy test at Visit 1
  • Secondary or malignant hypertension
  • Sitting SBP of 180 mmHg or more
  • Patients who are treated with candesartan 16 mg in combination with a diuretic or with candesartan 32 mg with or without any additional antihypertensive treatment
  • Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
  • Angina pectoris requiring more treatment than short-acting nitrates
  • Chronic use of NSAIDs
  • Aortic or mitral valve stenosis
  • Cardiac failure requiring treatment
  • Cardiac arrhythmia requiring treatment
  • Gout
  • Renal artery stenosis or kidney transplantation
  • Intravascular volume depletion
  • Hypersensitivity to any component of the investigational products
  • Concomitant disease which may interfere with the assessment of the patient
  • Past or present alcohol or drug abuse, or any condition associated with poor compliance
  • Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
  • Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
  • Previous enrolment in the present study
  • S-creatinine of 180 μmol/l or above for men and of 140 μmol/l or above for women
  • S-sodium or S-potassium outside the reference range
  • Less than 85% compliance with study medication during the run-in phase
  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: NCT00383929

  Show 134 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Established Brands HTN/CHF Medical Sience Director, MD AstraZeneca
Principal Investigator: Gerd Bonner, MD MEDIAN Kliniken Bad Krozingen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00383929     History of Changes
Other Study ID Numbers: D2456C00001, Eudract No. 2005-005718-19
Study First Received: October 3, 2006
Last Updated: March 19, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide

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 August 28, 2014