Trial Outcomes & Findings for Candesartan Effect in Second Stage Arterial Hypertension (NCT NCT00621153)

Results Overview

Mean of the changed DBP from baseline after 4 weeks

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

214 participants

Primary outcome timeframe

4 weeks

Results posted on

2010-03-23

Participant Flow

253 enrolled, 20 screening failure, 223 randomised, 198 completed

Participant milestones

Participant milestones
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy
Overall Study STARTED	117	116
Overall Study Discontinued	20	15
Overall Study COMPLETED	97	101
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy
Overall Study Safety Reason	8	7
Overall Study Adverse Event	3	2
Overall Study Lost to Follow-up	5	1
Overall Study Withdrawal by Subject	4	5

Baseline Characteristics

Candesartan Effect in Second Stage Arterial Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy n=117 Participants candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy n=116 Participants candesartan cilexetil monotherapy	Total n=233 Participants Total of all reporting groups
Age Continuous	51.00 years STANDARD_DEVIATION 10 • n=5 Participants	47.80 years STANDARD_DEVIATION 10 • n=7 Participants	48.90 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	38 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	78 Participants n=7 Participants	153 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Mean of the changed DBP from baseline after 4 weeks

Outcome measures

Outcome measures
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy n=111 Participants candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy n=113 Participants candesartan cilexetil monotherapy
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy	-17.0 mmHg Standard Deviation 0.89	-14.1 mmHg Standard Deviation 0.88

SECONDARY outcome

Timeframe: 4 weeks

Mean of the changed SBP from baseline after 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Percent of the patients achieving goal DBP and SBP after 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Percent of patients achieving goal of DBP

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Changed SBP from baseline after 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Change of hs-CRP from basline after 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Percent of the number of returened pills to the number of prescrited pills

Outcome measures

Outcome data not reported

Adverse Events

Candesartan Cilexetil/Hydroclorozide Combination Therapy

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Candesartan Cilexetil Monotherapy

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy
Renal and urinary disorders Breast clacifications	0.00% 0/111	0.88% 1/113
Skin and subcutaneous tissue disorders Scrub typhus	0.00% 0/111	0.88% 1/113
Gastrointestinal disorders Anal fistula	0.90% 1/111	0.00% 0/113

Other adverse events

Other adverse events
Measure	Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy	Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy
Nervous system disorders Dizziness	5.4% 6/111	2.7% 3/113

Additional Information

Gerard Lynch

AstraZeneca

Phone: +44 1509 64589

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60