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

NCT ID: NCT03667677

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-07-01

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.

Conditions

Hypertension; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Tandospirone + Amlodipine

Group Type: EXPERIMENTAL

Tandospirone + Amlodipine

Intervention Type: DRUG

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).

Group 2

Tandospirone placebo + Amlodipine

Group Type: EXPERIMENTAL

Tandospirone placebo + Amlodipine

Intervention Type: DRUG

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).

Group 3

Tandospirone + Amlodipine placebo

Group Type: EXPERIMENTAL

Tandospirone + Amlodipine placebo

Intervention Type: DRUG

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).

Group 4

Tandospirone placebo + Amlodipine placebo

Group Type: PLACEBO_COMPARATOR

Tandospirone placebo + Amlodipine placebo

Intervention Type: DRUG

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).

Interventions

Tandospirone + Amlodipine

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

Tandospirone placebo + Amlodipine

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

Tandospirone + Amlodipine placebo

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

Tandospirone placebo + Amlodipine placebo

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. An age of 60 - 80 years old;

2. 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;

3. A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;

4. Informed consent signed.

Exclusion Criteria

1. Secondary hypertension;

2. Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg

3. Hypertension with target organ damage;

4. 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);

5. Diabetes and dyslipidemia;

6. Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;

7. Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;

8. 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);

9. Uncontrolled thyroid diseases;

10. Severe or unstable central nervous system diseases;

11. Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;

12. Having been diagnosed with alcohol or drug abuse within the past 1 year;

13. Presenting the risk of suicide, self-injury, and hurt others;

14. Having participated in other clinical studies within the past 3 months;

15. Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.

16. Breastfeeding, pregnancy, or a pregnancy plan during the study;

17. Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xie Peng

Professor of Neurology, Yongchuan Hospital of Chongqing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Beijing Haidian Section of Peking University Third Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Yongchuan Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Zhongda Hospital of Southeast University

Nanjing, Giangsu, China

Kailuan General Hospital

Tangshan, Hebei, China

the First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Countries

China

Central Contacts

Peng Xie

Role: CONTACT

xiepeng@cqmu.edu.cn

86-023-68485490

References

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.

Reference Type: BACKGROUND

PMID: 24433257 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25960656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25164965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24987456 (View on PubMed)

Other Identifiers

CES-TAHA

Identifier Type: -

Identifier Source: org_study_id