Trial Outcomes & Findings for Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension (NCT NCT00527514)

NCT ID: NCT00527514

Last Updated: 2009-11-11

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

185 participants

Primary outcome timeframe

Baseline to 12 Weeks

Results posted on

2009-11-11

Participant Flow

Participants were recruited at 18 US sites over 4 months (September 2007 to December 2007) from each physician's clientele base. Approximately 150 eligible participants, men and women at least 18 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment

After placebo treatment, participants with a mean systolic blood pressure (SBP)≥140 mmHg and ≤199 mmHg or a mean diastolic BP (DBP)≥90 and ≤109 mmHg with a difference between mean SBPs ≤15 mmHg and a mean 8-hr daytime SBP of ≥135 mmHg and ≤199 mmHg, and mean 8-hr daytime DBP of \<110 mmHg by ambulatory BP monitoring were considered eligible.

Participant milestones

Participant milestones
Measure	Amlodipine and Olmesartan, if Necessary All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
Weeks 1-3: Amlodipine (Aml) 5mg STARTED	185
Weeks 1-3: Amlodipine (Aml) 5mg COMPLETED	184
Weeks 1-3: Amlodipine (Aml) 5mg NOT COMPLETED	1
Weeks 4-6: Aml 5mg+Olmesartan 20 mg STARTED	180
Weeks 4-6: Aml 5mg+Olmesartan 20 mg COMPLETED	178
Weeks 4-6: Aml 5mg+Olmesartan 20 mg NOT COMPLETED	2
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg STARTED	161
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg COMPLETED	158
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg NOT COMPLETED	3
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg STARTED	134
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg COMPLETED	132
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Amlodipine and Olmesartan, if Necessary All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
Weeks 1-3: Amlodipine (Aml) 5mg Adverse Event	1
Weeks 4-6: Aml 5mg+Olmesartan 20 mg Withdrawal by Subject	2
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg Adverse Event	1
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg Lost to Follow-up	1
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg Withdrawal by Subject	1
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg Adverse Event	1
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg Withdrawal by Subject	1

Baseline Characteristics

Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amlodipine and Olmesartan, if Necessary n=185 Participants Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP \>= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP \>= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP \>= 120/80 mm Hg
Age Continuous	56.8 years STANDARD_DEVIATION 9.28 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	26 Participants n=5 Participants
Race/Ethnicity, Customized White	144 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Region of Enrollment United States	185 participants n=5 Participants
Stage of Hypertension Stage 1	82 Participants n=5 Participants
Stage of Hypertension Stage 2	103 Participants n=5 Participants
24-Hour Ambulatory Diastolic Blood Pressure	85.8 mm Hg STANDARD_DEVIATION 7.91 • n=5 Participants
24-hour Ambulatory Systolic Blood Pressure	144.6 mm Hg STANDARD_DEVIATION 10.88 • n=5 Participants
Heart Rate	75.1 beats/minute STANDARD_DEVIATION 10.82 • n=5 Participants
Systolic Blood Pressure	158.2 mm Hg STANDARD_DEVIATION 12.63 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=172 Participants
Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring	-21.4 mm Hg Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=172 Participants
Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure Daytime	-23.1 mm Hg Standard Deviation 0.92
Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure Nighttime	-18.5 mm Hg Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline to end of week 3

Population: ITT (efficacy cohort)

Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=185 Participants
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.	-10.1 mm Hg Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline to end of week 6

Population: ITT (efficacy cohort)

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=179 Participants
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.	-18.0 mm Hg Standard Error 0.92

SECONDARY outcome

Timeframe: Baseline to end of week 9

Population: ITT (efficacy cohort)

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=160 Participants
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group	-20.5 mm Hg Standard Error 1.01

SECONDARY outcome

Timeframe: Baseline to end end of week 12

Population: ITT (efficacy cohort)

Outcome measures

Outcome measures
Measure	Overall Active Treatment Period n=133 Participants
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group	-24.6 mm Hg Standard Error 1.18

Adverse Events

Amlodipine 5 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Amlodipine 5mg and Olmesartan 20 mg

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Amlodipine 5mg and Olmesartan 40 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Amlodipine 10 mg and Olmesartan 40 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Amlodipine 5 mg n=185 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 5mg and Olmesartan 20 mg n=180 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 5mg and Olmesartan 40 mg n=161 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 10 mg and Olmesartan 40 mg n=134 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
Injury, poisoning and procedural complications Limb amputation	0.00% 0/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.00% 0/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.62% 1/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.00% 0/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
Vascular disorders Transient ischemic attack	0.00% 0/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.00% 0/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.00% 0/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.75% 1/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.

Other adverse events

Other adverse events
Measure	Amlodipine 5 mg n=185 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 5mg and Olmesartan 20 mg n=180 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 5mg and Olmesartan 40 mg n=161 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.	Amlodipine 10 mg and Olmesartan 40 mg n=134 participants at risk All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
Nervous system disorders Dizziness	1.1% 2/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.7% 3/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.2% 2/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.75% 1/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.54% 1/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.1% 2/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.2% 2/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	2.2% 3/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
Infections and infestations Nasopharyngitis	0.54% 1/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	5.0% 9/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.2% 2/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	3.7% 5/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
General disorders Oedema Peripheral	1.6% 3/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	2.8% 5/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.2% 2/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.5% 2/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
Infections and infestations Upper respiratory tract infection	0.54% 1/185 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	2.2% 4/180 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	1.9% 3/161 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.	0.75% 1/134 • 12 week treatment period plus 30 days after the last dose. Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.

Additional Information

John Raia

Daiichi Sankyo

Phone: (973) 630-2683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "If identified by Daiichi Sankyo, Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by Study Site."
Publication restrictions are in place

Restriction type: OTHER