Trial Outcomes & Findings for Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics) (NCT NCT00690612)

Last Updated: 2011-07-12

Results Overview

Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

Every 3 months- baseline to final visit

Results posted on

2011-07-12

Participant Flow

Hypertensive children aged 1 to \<11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe.

Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan.

Participant milestones

Participant milestones
Measure	Atacand Candesartan Cilexetil candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Overall Study STARTED	35
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Atacand Candesartan Cilexetil candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atacand Candesartan Cilexetil n=35 Participants candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Age Continuous <=11 years	4.4 Years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months- baseline to final visit

Outcome measures

Outcome measures
Measure	Atacand Candesartan Cilexetil n=35 Participants candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).	-2.86 Millimeters of Mercury (mm Hg) Standard Deviation 11.97

PRIMARY outcome

Timeframe: every 3 months - baseline to final visit

Outcome measures

Outcome measures
Measure	Atacand Candesartan Cilexetil n=35 Participants candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).	-0.43 mm Hg Standard Deviation 12.26

Adverse Events

Atacand Candesartan Cilexetil

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atacand Candesartan Cilexetil n=35 participants at risk candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Infections and infestations Bronchopneumonia	2.9% 1/35
Metabolism and nutrition disorders Hyperkalaemia	2.9% 1/35
Blood and lymphatic system disorders Lymphoedema	2.9% 1/35

Other adverse events

Other adverse events
Measure	Atacand Candesartan Cilexetil n=35 participants at risk candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Gastrointestinal disorders Diarrhoea	17.1% 6/35
Gastrointestinal disorders Nausea	8.6% 3/35
Gastrointestinal disorders VOMITING	8.6% 3/35
General disorders PYREXIA	25.7% 9/35
General disorders FATIGUE	5.7% 2/35
Infections and infestations PHARYNGITIS	17.1% 6/35
Infections and infestations RHINITIS	17.1% 6/35
Infections and infestations NASOPHARYNGITIS	11.4% 4/35
Infections and infestations BRONCHITIS	8.6% 3/35
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.6% 3/35
Infections and infestations VARICELLA	8.6% 3/35
Infections and infestations ACUTE TONSILLITIS	5.7% 2/35
Infections and infestations GASTROENTERITIS	5.7% 2/35
Infections and infestations INFLUENZA	5.7% 2/35
Infections and infestations OTITIS MEDIA	5.7% 2/35
Infections and infestations OTITIS MEDIA ACUTE	5.7% 2/35
Infections and infestations TONSILLITIS	5.7% 2/35
Infections and infestations URINARY TRACT INFECTION	5.7% 2/35
Renal and urinary disorders ENURESIS	8.6% 3/35
Respiratory, thoracic and mediastinal disorders COUGH	14.3% 5/35
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	5.7% 2/35

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60