Trial Outcomes & Findings for A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient (NCT NCT00415623)

NCT ID: NCT00415623

Last Updated: 2021-02-11

Results Overview

Mean change in the trough SBP

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 305 participants
• Primary outcome timeframe: Baseline to Week 8
• Results posted on: 2021-02-11

Participant Flow

Twenty-four (24) centers in Japan

Consent was taken from 414 patients, 356 patients who met the screening criteria received amlodipine 5 mg. After the 8 weeks of screening treatment, patients who met the entry criteria for double-blind period were randomized to either the amlodipine 10 mg group or the amlodipine 5 mg group at a ratio of 1:1.

Participant milestones

Measure	Amlodipine 5 mg One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Overall Study STARTED	154	151
Overall Study COMPLETED	149	146
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Amlodipine 5 mg One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
Overall Study Adverse Event	3	4
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

Baseline characteristics by cohort

Measure	Amlodipine 5 mg n=154 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=151 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Total n=305 Participants Total of all reporting groups
Age, Customized < 20 years	0 partcipants n=5 Participants	0 partcipants n=7 Participants	0 partcipants n=5 Participants
Age, Customized 20 to 44 years	15 partcipants n=5 Participants	15 partcipants n=7 Participants	30 partcipants n=5 Participants
Age, Customized 45 to 64 years	75 partcipants n=5 Participants	70 partcipants n=7 Participants	145 partcipants n=5 Participants
Age, Customized >= 65 years	64 partcipants n=5 Participants	66 partcipants n=7 Participants	130 partcipants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	59 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	92 Participants n=7 Participants	176 Participants n=5 Participants
Region of Enrollment Japan	154 participants n=5 Participants	151 participants n=7 Participants	305 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Mean change in the trough SBP

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Change in Systolic Blood Pressure (SBP) From Baseline to Week 8	-7.0 mmHg Interval -8.8 to -5.2	-13.7 mmHg Interval -15.4 to -12.0	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Mean change in the trough DBP

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8	-2.7 mmHg Interval -3.9 to -1.4	-6.8 mmHg Interval -8.0 to -5.5	—

SECONDARY outcome

Timeframe: Baseline to Week 6 and Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)	-6.8 mmHg Interval -8.4 to -5.2	-13.9 mmHg Interval -15.5 to -12.4	—

SECONDARY outcome

Timeframe: Baseline to Week 6 and Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)	-2.5 mmHg Interval -3.6 to -1.4	-6.5 mmHg Interval -7.6 to -5.5	—

SECONDARY outcome

Timeframe: Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8	43 participants	66 participants	—

SECONDARY outcome

Timeframe: Week 6 and Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8	22 participants	52 participants	—

SECONDARY outcome

Timeframe: Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8	35 participants	61 participants	—

SECONDARY outcome

Timeframe: Week 6 and Week 8

Population: Full Analysis Set, Last Observation Carried Forward

Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old

Outcome measures

Measure	Amlodipine 5 mg n=151 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=150 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8	16 participants	44 participants	—

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.

Outcome measures

Measure	Amlodipine 5 mg n=147 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=146 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8 n=145 Participants
Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg	7.02 ng/mL Interval 6.5 to 7.5	6.83 ng/mL Interval 6.3 to 7.4	7.03 ng/mL Interval 6.6 to 7.5

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 8

Population: Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.

Outcome measures

Measure	Amlodipine 5 mg n=145 Participants One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.	Amlodipine 10 mg n=144 Participants Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.	Week 8 n=143 Participants
Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg	7.18 ng/mL Interval 6.7 to 7.7	16.9 ng/mL Interval 15.7 to 18.1	16.9 ng/mL Interval 15.7 to 18.2

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
• Publication restrictions are in place

Restriction type: OTHER