Trial Outcomes & Findings for Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension (NCT NCT00858702)

NCT ID: NCT00858702

Last Updated: 2017-10-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 105 participants
• Primary outcome timeframe: Baseline to week 8
• Results posted on: 2017-10-11

Participant Flow

A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.

After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.

Participant milestones

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic Tablet olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
Overall Study STARTED	53	52
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic Tablet olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	1	1
Overall Study Other	2	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

Baseline characteristics by cohort

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet n=53 Participants olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic n=52 Participants olmesartan medoxomil tablets and a diuretic once daily for 8 weeks	Total n=105 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 11.2 • n=93 Participants	57.4 years STANDARD_DEVIATION 9.4 • n=4 Participants	56.8 years STANDARD_DEVIATION 10.3 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	20 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Race/Ethnicity, Customized Japanese	53 Participants n=93 Participants	52 Participants n=4 Participants	105 Participants n=27 Participants
Region of Enrollment Japan	53 participants n=93 Participants	52 participants n=4 Participants	105 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.

Outcome measures

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet n=50 Participants olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic n=49 Participants olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85	34.0 Percent of participants	59.2 Percent of participants

SECONDARY outcome

Timeframe: At week 8

Population: Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.

Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.

Outcome measures

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet n=53 Participants olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic n=52 Participants olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)	0 Percent of participants	7.7 Percent of participants

SECONDARY outcome

Timeframe: At week 8

Population: Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.

Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.

Outcome measures

Measure	Olmesartan Tablets and a Calcium Channel Blocker Tablet n=52 Participants olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks	Olmesartan Medoxomil Tablets and a Diuretic n=52 Participants olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)	1.9 Percent of participants	44.2 Percent of participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Howard Kessler

Daiichi Sankyo

Phone: 732-590-5032

Email: hmkessler@dsi.com

Results disclosure agreements

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