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Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

Primary Purpose

Hypertension, Anxiety

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Tandospirone + Amlodipine

Tandospirone placebo + Amlodipine

Tandospirone + Amlodipine placebo

Tandospirone placebo + Amlodipine placebo

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Anxiety, Tandospirone, Amlodipine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

An age of 60 - 80 years old;
Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
Informed consent signed.

Exclusion Criteria:

Secondary hypertension;
Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
Hypertension with target organ damage;
Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
Diabetes and dyslipidemia;
Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L);
Uncontrolled thyroid diseases;
Severe or unstable central nervous system diseases;
Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
Having been diagnosed with alcohol or drug abuse within the past 1 year;
Presenting the risk of suicide, self-injury, and hurt others;
Having participated in other clinical studies within the past 3 months;
Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.
Breastfeeding, pregnancy, or a pregnancy plan during the study;
Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.

Sites / Locations

Beijing Friendship Hospital of Capital Medical University
Beijing Haidian Section of Peking University Third Hospital
Xuanwu Hospital of Capital Medical University
Yongchuan Hospital of Chongqing Medical University
Zhongda Hospital of Southeast University
Kailuan General Hospital
the First Affiliated Hospital of Shanxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Tandospirone + Amlodipine

Tandospirone placebo + Amlodipine

Tandospirone + Amlodipine placebo

Tandospirone placebo + Amlodipine placebo

Outcomes

Primary Outcome Measures

Office systolic blood pressure and diastolic blood pressure

14-item Hamilton Anxiety Scale(HAMA)

HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.

Secondary Outcome Measures

the proportion of patients who met blood pressure control goal( < 140/90mmHg)

24-hour ambulatory blood pressure monitoring(ABPM)

the proportion of participants with an at least 50% reduction of HAMA score from baseline

the proportion of participants showing 7 or less on HAMA

20-item Self-Rating Anxiety Scale(SAS)

SAS-20 are rated on 4 grades ranging from 1(a little of the time) to 4(most of the time).The standard score ranges are 25-49 (normal range), 50-59 (mild anxiety), 60-69(moderate anxiety), and 70 or more(severe anxiety).

heart rate variability(HRV)

17-item Hamilton Depression Rating Scale(HAMD)

HAMD-17 are rated on 5 grades ranging from 0 (no symptom) to 4 (very severe). 7 or less on HAMD means no depression, 7 to 17 on HAMD means mild depression, 18 to 23 on HAMD means moderate depression, and 24 or more on HAMD means severe depression.

Clinical Global Impression-Improvement(CGI-I)

Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)

Q-LES-Q are rated on 5 grades ranging from 1 to 5 points.

Full Information

NCT ID

NCT03667677

First Posted

September 6, 2018

Last Updated

November 30, 2018

Sponsor

Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03667677

Brief Title

Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

Official Title

Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Anticipated)

Primary Completion Date

February 1, 2020 (Anticipated)

Study Completion Date

July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

Detailed Description

In recent years, many studies have found that elevated blood pressure is associated with anxiety. It has been report that the incidence of hypertension with anxiety is 25%-54%. The studies have confirmed that anxiety can significantly reduce the antihypertensive effect. Therefore, anxiolytics can increase the antihypertensive effect in patients with hypertension and anxiety. However, there is currently no standard treatment for patients with hypertension and anxiety, and few clinical studies have focused on the treatment of these neglected patients. Improvement on hypertension through relieving anxiety and relief of anxiety through lowering hypertension are lack of clinical studies to prove. This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Anxiety

Keywords

Hypertension, Anxiety, Tandospirone, Amlodipine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Tandospirone + Amlodipine

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Tandospirone placebo + Amlodipine

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Tandospirone + Amlodipine placebo

Arm Title

Group 4

Arm Type

Placebo Comparator

Arm Description

Tandospirone placebo + Amlodipine placebo

Intervention Type

Drug

Intervention Name(s)

Tandospirone + Amlodipine

Intervention Description

The first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).

Intervention Type

Drug

Intervention Name(s)

Tandospirone placebo + Amlodipine

Intervention Description

The second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).

Intervention Type

Drug

Intervention Name(s)

Tandospirone + Amlodipine placebo

Intervention Description

The third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).

Intervention Type

Drug

Intervention Name(s)

Tandospirone placebo + Amlodipine placebo

Intervention Description

The fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).

Primary Outcome Measure Information:

Title

Office systolic blood pressure and diastolic blood pressure

Time Frame

Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks

Title

14-item Hamilton Anxiety Scale(HAMA)

Description

Time Frame

Change from Baseline HAMA score at 4 weeks and 8 weeks

Secondary Outcome Measure Information:

Title

the proportion of patients who met blood pressure control goal( < 140/90mmHg)

Time Frame

Week 8

Title

24-hour ambulatory blood pressure monitoring(ABPM)

Time Frame

Change from Baseline ABPM at 4 weeks and 8 weeks

Title

the proportion of participants with an at least 50% reduction of HAMA score from baseline

Time Frame

Week 8

Title

the proportion of participants showing 7 or less on HAMA

Time Frame

Week 8

Title

20-item Self-Rating Anxiety Scale(SAS)

Description

Time Frame

Change from Baseline SAS score at 4 weeks and 8 weeks

Title

heart rate variability(HRV)

Time Frame

Change from Baseline HRV at 4 weeks and 8 weeks

Title

17-item Hamilton Depression Rating Scale(HAMD)

Description

Time Frame

Change from Baseline HAMD score at 4 weeks and 8 weeks

Title

Clinical Global Impression-Improvement(CGI-I)

Time Frame

Change from Baseline CGI-I score at 4 weeks and 8 weeks

Title

Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)

Description

Q-LES-Q are rated on 5 grades ranging from 1 to 5 points.

Time Frame

Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: An age of 60 - 80 years old; Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period; A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder; Informed consent signed. Exclusion Criteria: Secondary hypertension; Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg Hypertension with target organ damage; Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ); Diabetes and dyslipidemia; Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure; Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea; Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L); Uncontrolled thyroid diseases; Severe or unstable central nervous system diseases; Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment; Having been diagnosed with alcohol or drug abuse within the past 1 year; Presenting the risk of suicide, self-injury, and hurt others; Having participated in other clinical studies within the past 3 months; Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications. Breastfeeding, pregnancy, or a pregnancy plan during the study; Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng Xie

Phone

86-023-68485490

xiepeng@cqmu.edu.cn

Facility Information:

Facility Name

Beijing Friendship Hospital of Capital Medical University

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Beijing Haidian Section of Peking University Third Hospital

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Xuanwu Hospital of Capital Medical University

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Yongchuan Hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

Country

China

Facility Name

Zhongda Hospital of Southeast University

City

Nanjing

State/Province

Giangsu

Country

China

Facility Name

Kailuan General Hospital

City

Tangshan

State/Province

Hebei

Country

China

Facility Name

the First Affiliated Hospital of Shanxi Medical University

City

Taiyuan

State/Province

Shanxi

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Any public report on the results of this study will not disclose personal information of the participants.

Citations:

PubMed Identifier

24433257

Citation

Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.

Results Reference

background

PubMed Identifier

25960656

Citation

Pan Y, Cai W, Cheng Q, Dong W, An T, Yan J. Association between anxiety and hypertension: a systematic review and meta-analysis of epidemiological studies. Neuropsychiatr Dis Treat. 2015 Apr 22;11:1121-30. doi: 10.2147/NDT.S77710. eCollection 2015.

Results Reference

background

PubMed Identifier

25164965

Citation

Byrd JB, Brook RD. Anxiety in the "age of hypertension". Curr Hypertens Rep. 2014 Oct;16(10):486. doi: 10.1007/s11906-014-0486-0.

Results Reference

background

PubMed Identifier

24987456

Citation

Kretchy IA, Owusu-Daaku FT, Danquah SA. Mental health in hypertension: assessing symptoms of anxiety, depression and stress on anti-hypertensive medication adherence. Int J Ment Health Syst. 2014 Jun 21;8:25. doi: 10.1186/1752-4458-8-25. eCollection 2014.

Results Reference

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Learn more about this trial

Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

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