Trial Outcomes & Findings for Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP) (NCT NCT00348686)

NCT ID: NCT00348686

Last Updated: 2012-04-02

Results Overview

Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 315 participants
• Primary outcome timeframe: At Baseline and 24 weeks
• Results posted on: 2012-04-02

Participant Flow

Milestone date: 15 June 2006 (FSI) ~ 05 June 2008 (LSLV) Type of location: General Hospital; 333 subjects enrolled, but 18 subjects failed to be randomized, 315 subjects were randomized to study.

Screening period: Laboratory test (Creatinine, potassium, ALT, etc)

Participant milestones

Measure	Candesartan Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Overall Study STARTED	315
Overall Study COMPLETED	249
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Measure	Candesartan Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Overall Study Withdrawal by Subject	45
Overall Study Adverse Event	5
Overall Study Protocol Violation	6
Overall Study Lost to Follow-up	2
Overall Study Multiple Reasons	8

Baseline Characteristics

Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)

Baseline characteristics by cohort

Measure	Candesartan n=315 Participants
Age Continuous Average age of subjects who participated	49.90 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants
Sex: Female, Male Male	234 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Baseline and 24 weeks

Population: Followed Intent-to-treat analysis

Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.

Outcome measures

Measure	Candesartan n=292 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Percent Change of B Type Natriuretic Peptides (BNP) Level	-29.2 Percent Change Interval -35.3 to -16.7

SECONDARY outcome

Timeframe: At Baseline and 24 weeks

Population: Only 245 patients who have reliable Echocardiac data were analyzed.

Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.

Outcome measures

Measure	Candesartan n=245 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index	-10.90 g/m^2 Interval -14.0 to -7.0

SECONDARY outcome

Timeframe: At Baseline and 24 weeks

Population: Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.

Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.

Outcome measures

Measure	Candesartan n=302 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Change of Systolic Blood Pressure (SBP)	-32.0 mmHg Interval -35.0 to -30.0

SECONDARY outcome

Timeframe: At Baseline and 24 weeks

Population: Last Observational carried forward

Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.

Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.

Outcome measures

Measure	Candesartan n=302 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Change of Diastolic Blood Pressure (DBP)	-20.0 mmHg Interval -20.0 to -18.0

SECONDARY outcome

Timeframe: At Baseline and 24 weeks

Population: Only 201 patients are available for analysis.

Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.

Outcome measures

Measure	Candesartan n=201 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only	-18.9 percent change Interval -33.0 to -6.6

SECONDARY outcome

Timeframe: At Baseline and 24 weeks

Population: Only 91 patients are available for analysis

Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.

Outcome measures

Measure	Candesartan n=91 Participants Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine	-36.1 percent change Interval -57.9 to -24.3

Adverse Events

Candesartan

Serious events: 8 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Candesartan
Gastrointestinal disorders Left paraduodenal hernia	0.32% 1/315
Gastrointestinal disorders Rectal prolapse aggravated	0.32% 1/315
Vascular disorders Cerebral infarction	0.32% 1/315
Renal and urinary disorders Uterine myoma aggravated	0.32% 1/315
General disorders Cervical disc herniation aggravated	0.32% 1/315
Respiratory, thoracic and mediastinal disorders Pneumonia with effusion in the right chest	0.32% 1/315
Skin and subcutaneous tissue disorders Granuloma inguinale	0.32% 1/315
Cardiac disorders Acute myocardial infarction	0.32% 1/315

Other adverse events

Measure	Candesartan
Nervous system disorders Headache	7.3% 23/315
Nervous system disorders Dizziness	5.1% 16/315

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60